OnX - A1 SRI-0202027

GUDID 10850039704083

Full arch provisional restoration for all-on-x cases. Denture teeth for removable permanent full dentures

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID10850039704083
NIH Device Record Key8d2b56f3-96ed-46c8-af23-84ba3bbb898a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnX - A1
Version Model NumberSRI-0202027
Catalog NumberSRI-0202027
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

Device Dimensions

Total Volume1 Liter
Total Volume1 Liter
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Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
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Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039704086 [Primary]
GS110850039704083 [Package]
Contains: 00850039704086
Package: Box [1 Units]
In Commercial Distribution

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 Date2022-03-08
Device Publish Date2022-02-28

Devices Manufactured by Sprintray, Inc.

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00850039704932 - OnX Tough 2 Bleach 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
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
00850039704918 - SprintRay Retainer2024-10-25 SprintRay Retainer is an alternative to traditional thermoplastic material used for the fabrication of retainers. It is intended
00850039704741 - Ceramic Crown - A1 - 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
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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