SprintRay Apex Base - Dark Reddish Pink - 1 Kg

GUDID 00850039704673

APEX Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID00850039704673
NIH Device Record Key1bc9c1a2-dd5c-4a07-930e-0b47e12acfd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprintRay Apex Base - Dark Reddish Pink - 1 Kg
Version Model NumberSRI-0202155
Company DUNS063005260
Company NameSprintray, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100850039704673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-26
Device Publish Date2024-02-16

Devices Manufactured by Sprintray, Inc.

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00850039704949 - OnX Tough 2 A1 Single-unit Capsule2024-12-17 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850039704956 - OnX Tough 2 A1 Single-unit Capsule 3-Pack2024-12-17 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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00850039704758 - Ceramic Crown - A2 - Single-unit Capsule 1-Pack2024-09-17 SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D im
00850039704765 - Ceramic Crown - B1 - Single-unit Capsule 1-Pack2024-09-17 SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D im

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