TS Cantilever Arms

GUDID D8199002165

SPECIALTY APPLIANCES, LLC

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• Primary Device ID: D8199002165
• NIH Device Record Key: 21028ec5-65ea-4724-89c3-280b5c80f0c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TS Cantilever Arms
• Version Model Number: 900216
• Company DUNS: 106645484
• Company Name: SPECIALTY APPLIANCES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8199002160 [Primary]
HIBCC	D8199002165 [Package]; Contains: D8199002160; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• ECN: Clamp, Wire, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-25
• Device Publish Date: 2023-12-15

Devices Manufactured by SPECIALTY APPLIANCES, LLC

• D8199006250 - Upper ROC Kit for Herbst: 2024-04-30
• D8199006260 - Lower ROC Kit for Herbst: 2024-04-30
• D8199006270 - Upper Crown Kit for Herbst: 2024-04-30
• D8199006280 - Lower Crown Kit for Herbst: 2024-04-30
• D8199006290 - ROC Kit: 2024-04-30
• D8199006300 - Crown Kit: 2024-04-30
• D8199013170 - OnBrace Kit: 2024-04-30
• D8199013182 - OnBrace Crown UR2 (5/pk): 2024-03-18