SprintRay OnX Tough - Bleach SRI-0202120

GUDID 00850039704536

The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID00850039704536
NIH Device Record Key17803818-0c46-4c1a-9ebb-925239f0a44b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprintRay OnX Tough - Bleach
Version Model NumberSRI-0202120
Catalog NumberSRI-0202120
Company DUNS063005260
Company NameSprintray, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039704536 [Primary]

FDA Product Code

PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-16
Device Publish Date2023-05-08

Devices Manufactured by Sprintray, Inc.

00850070544597 - APEX Flex - Standard Pink2025-07-29 SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentu
00850070544603 - APEX Flex - Light Pink2025-07-29 SprintRay APEX Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentu
00850070544412 - APEX Base - Light Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544429 - APEX Base - Original Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544436 - APEX Base - Dark Reddish Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544443 - APEX Base - Opaque Original Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544450 - OnX Tough 2 - A1 - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850070544559 - OnX Tough 2 - A2 - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp

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