G4 NiTi Lingual Wire .013 Medium Lower

GUDID D8199512540

SPECIALTY APPLIANCES, LLC

Orthodontic archwire

• Primary Device ID: D8199512540
• NIH Device Record Key: cb974eac-5257-4112-ac4b-db57f70e9f4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G4 NiTi Lingual Wire .013 Medium Lower
• Version Model Number: 951254
• 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	D8199512540 [Primary]

FDA Product Code

• DZC: 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: 2025-07-28
• Device Publish Date: 2025-07-18

Devices Manufactured by SPECIALTY APPLIANCES, LLC

• D8199512450 - G4 NiTi Lingual Wire .010 Small Upper: 2025-07-28
• D8199512460 - G4 NiTi Lingual Wire .010 Small Lower: 2025-07-28
• D8199512470 - G4 NiTi Lingual Wire .010 Medium Upper: 2025-07-28
• 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