OnBrace Crown UL6 (5/pk)

GUDID D8199013292

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary
Primary Device IDD8199013292
NIH Device Record Keyfc444080-e6fd-4941-8d54-8b9b64ae5c50
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnBrace Crown UL6 (5/pk)
Version Model Number901329
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
HIBCCD8199013290 [Primary]
HIBCCD8199013292 [Package]
Contains: D8199013290
Package: [5 Units]
In Commercial Distribution

FDA Product Code

ECMBand, Preformed, Orthodontic
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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D8199007380 - Printed Pre-Formed Left Cantilever 12mm (Single)2025-02-17
D8199007390 - Printed Pre-Formed Left Cantilever 14mm (Single)2025-02-17
D8199007400 - Printed Pre-Formed Right Cantilever 8mm (Single)2025-02-17
D8199007410 - Printed Pre-Formed Right Cantilever 10mm (Single)2025-02-17
D8199007420 - Printed Pre-Formed Right Cantilever 12mm (Single)2025-02-17
D8199007430 - Printed Pre-Formed Right Cantilever 14mm (Single)2025-02-17

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