Upper ROC Kit for Herbst

GUDID D8199006250

SPECIALTY APPLIANCES, LLC

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• Primary Device ID: D8199006250
• NIH Device Record Key: e46d73b9-b586-46ac-be5c-835ca939c666
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Upper ROC Kit for Herbst
• Version Model Number: 900625
• 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: true
• 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	D8199006250 [Primary]

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: 2024-04-30
• Device Publish Date: 2024-04-22

Devices Manufactured by SPECIALTY APPLIANCES, LLC

• D8199006250 - Upper ROC Kit for Herbst: 2024-04-30
• 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