OnBrace Crown LL3 (5/pk)

GUDID D8199013402

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary
Primary Device IDD8199013402
NIH Device Record Keyd802a9ed-b866-43da-a7b2-1d5acde95695
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnBrace Crown LL3 (5/pk)
Version Model Number901340
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
HIBCCD8199013400 [Primary]
HIBCCD8199013402 [Package]
Contains: D8199013400
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

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D8199006270 - Upper Crown Kit for Herbst2024-04-30
D8199006280 - Lower Crown Kit for Herbst2024-04-30
D8199006290 - ROC Kit2024-04-30
D8199006300 - Crown Kit2024-04-30
D8199013170 - OnBrace Kit2024-04-30
D8199013182 - OnBrace Crown UR2 (5/pk)2024-03-18

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