17mm Mini Screw Button Type

GUDID D8199015040

SPECIALTY APPLIANCES, LLC

Orthodontic anchoring screw
Primary Device IDD8199015040
NIH Device Record Key2135ca6e-6dda-4bab-b973-5a2b82842dd5
Commercial Distribution StatusIn Commercial Distribution
Brand Name17mm Mini Screw Button Type
Version Model Number901504
Company DUNS106645484
Company NameSPECIALTY APPLIANCES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
HIBCCD8199015040 [Primary]

FDA Product Code

OATImplant, Endosseous, Orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


[D8199015040]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-27
Device Publish Date2024-11-19

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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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