Crown HT A2 Single-Unit Capsule 3-Pack

GUDID 00850070544054

SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single 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 ID00850070544054
NIH Device Record Key25c71a9b-4e19-43af-b53f-74f4418a7af6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrown HT A2 Single-Unit Capsule 3-Pack
Version Model NumberSRI-0204031
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850070544054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-05
Device Publish Date2025-02-25

Devices Manufactured by Sprintray, Inc.

00850070544009 - Crown HT A1 Single-Unit Capsule2025-03-05 SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed defin
00850070544016 - Crown HT A2 Single-Unit Capsule2025-03-05 SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed defin
00850070544023 - Crown HT Bleach Single-Unit Capsule2025-03-05 SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed defin
00850070544030 - Crown HT B1 Single-Unit Capsule2025-03-05 SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed defin
00850070544047 - Crown HT A1 Single-Unit Capsule 3-Pack2025-03-05 SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed defin
00850070544054 - Crown HT A2 Single-Unit Capsule 3-Pack2025-03-05SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single 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.
00850070544054 - Crown HT A2 Single-Unit Capsule 3-Pack2025-03-05 SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed defin
00850070544061 - Crown HT B1 Single-Unit Capsule 3-Pack2025-03-05 SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed defin
00850070544078 - Crown HT Bleach Single-Unit Capsule 3-Pack2025-03-05 SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed defin

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