OnBrace Crown UR6 w/ AWT (5/pk)

GUDID D8199014182

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary

• Primary Device ID: D8199014182
• NIH Device Record Key: ef051c57-764c-49a0-9d90-e2e013f3e9c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnBrace Crown UR6 w/ AWT (5/pk)
• Version Model Number: 901418
• 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	D8199014180 [Primary]
HIBCC	D8199014182 [Package]; Contains: D8199014180; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• ECM: Band, Preformed, Orthodontic
• ELZ: Crown, Preformed

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: 2024-10-02
• Device Publish Date: 2024-09-24

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