OnBrace Crown LL6 (5/pk)

GUDID D8199013432

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary
Primary Device IDD8199013432
NIH Device Record Key6ad5b99a-3f9f-4ca6-8cd4-6ef7a8479776
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnBrace Crown LL6 (5/pk)
Version Model Number901343
Company DUNS106645484
Company NameSPECIALTY APPLIANCES, LLC
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8199013430 [Primary]
HIBCCD8199013432 [Package]
Contains: D8199013430
Package: [5 Units]
In Commercial Distribution

FDA Product Code

ELZCrown, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-18
Device Publish Date2024-03-08

Devices Manufactured by SPECIALTY APPLIANCES, LLC

D8199013480 - OnBrace Kit w/ Archwire Tubes2024-10-02
D8199013492 - OnBrace Crown UR2 w/ AWT (5/pk)2024-10-02
D8199013602 - OnBrace Crown UL6 w/ AWT (5/pk)2024-10-02
D8199013612 - OnBrace Crown UL7 w/ AWT (5/pk)2024-10-02
D8199013622 - OnBrace Crown UL8 w/ AWT (5/pk)2024-10-02
D8199013632 - OnBrace Crown LR2 w/ AWT (5/pk)2024-10-02
D8199013642 - OnBrace Crown LR3 w/ AWT (5/pk)2024-10-02
D8199013652 - OnBrace Crown LR4 w/ AWT (5/pk)2024-10-02

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