Upper ROC Pack for Herbst UR5

GUDID D8199006322

SPECIALTY APPLIANCES, LLC

Orthodontic metal band

• Primary Device ID: D8199006322
• NIH Device Record Key: f682b1b9-02ec-4d7c-9aad-a5bb7ded4eb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Upper ROC Pack for Herbst UR5
• Version Model Number: 900632
• 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	D8199006320 [Primary]
HIBCC	D8199006322 [Package]; Contains: D8199006320; Package: [5 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: 2023-11-07
• Device Publish Date: 2023-10-30

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• D8199512480 - G4 NiTi Lingual Wire .010 Medium Lower: 2025-07-28
• D8199512490 - G4 NiTi Lingual Wire .010 Large Upper: 2025-07-28
• D8199512500 - G4 NiTi Lingual Wire .010 Large Lower: 2025-07-28
• D8199512510 - G4 NiTi Lingual Wire .013 Small Upper: 2025-07-28
• D8199512520 - G4 NiTi Lingual Wire .013 Small Lower: 2025-07-28