Pedo OnBrace Crown UR5 (5/pk)

GUDID D8199013982

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary

• Primary Device ID: D8199013982
• NIH Device Record Key: 0f513d25-8b08-47cc-831b-13654d06339f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedo OnBrace Crown UR5 (5/pk)
• Version Model Number: 901398
• 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	D8199013980 [Primary]
HIBCC	D8199013982 [Package]; Contains: D8199013980; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• 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

Devices Manufactured by SPECIALTY APPLIANCES, LLC

• D8199013480 - OnBrace Kit w/ Archwire Tubes: 2024-10-02
• D8199013492 - OnBrace Crown UR2 w/ AWT (5/pk): 2024-10-02
• D8199013602 - OnBrace Crown UL6 w/ AWT (5/pk): 2024-10-02
• D8199013612 - OnBrace Crown UL7 w/ AWT (5/pk): 2024-10-02
• D8199013622 - OnBrace Crown UL8 w/ AWT (5/pk): 2024-10-02
• D8199013632 - OnBrace Crown LR2 w/ AWT (5/pk): 2024-10-02
• D8199013642 - OnBrace Crown LR3 w/ AWT (5/pk): 2024-10-02
• D8199013652 - OnBrace Crown LR4 w/ AWT (5/pk): 2024-10-02