Upper ROC Kit for Herbst

GUDID D8199006250

SPECIALTY APPLIANCES, LLC

Orthodontic metal band
Primary Device IDD8199006250
NIH Device Record Keye46d73b9-b586-46ac-be5c-835ca939c666
Commercial Distribution StatusIn Commercial Distribution
Brand NameUpper ROC Kit for Herbst
Version Model Number900625
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 Kittrue
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
HIBCCD8199006250 [Primary]

FDA Product Code

ECNClamp, Wire, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-30
Device Publish Date2024-04-22

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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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