Printed Pre-Formed 10mm Cantilever Set

GUDID D8199007450

SPECIALTY APPLIANCES, LLC

Orthodontic power arm
Primary Device IDD8199007450
NIH Device Record Keyd47e5000-61fc-44fe-82b9-545bc2edb323
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrinted Pre-Formed 10mm Cantilever Set
Version Model Number900745
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
HIBCCD8199007450 [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 Date2025-02-17
Device Publish Date2025-02-07

Devices Manufactured by SPECIALTY APPLIANCES, LLC

D8199007350 - Printed Pre-Formed Left Cantilever 8mm (Single)2025-02-17
D8199007360 - Printed Pre-Formed Left Cantilever 10mm (Single)2025-02-17
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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