Digital Temp A2 Single-Unit Capsule 3-Pack

GUDID 00850070544139

SprintRay Digital Temp is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed temporary full single crowns; temporary partial crowns in anterior and posterior area, individual and fixed single temporary veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID00850070544139
NIH Device Record Keyc48f9b92-127e-4cec-8d08-ec7f2fc51831
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital Temp A2 Single-Unit Capsule 3-Pack
Version Model NumberSRI-0204024
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

Device Dimensions

Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850070544139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-19
Device Publish Date2025-03-11

Devices Manufactured by Sprintray, Inc.

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
00850070544566 - OnX Tough 2 - B1 - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850070544573 - OnX Tough 2 - Bleach - 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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