OnBrace Crown LR4 (5/pk)

GUDID D8199013342

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary

• Primary Device ID: D8199013342
• NIH Device Record Key: 3693b138-c493-4902-9b3b-555ff2cfb570
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnBrace Crown LR4 (5/pk)
• Version Model Number: 901334
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8199013340 [Primary]
HIBCC	D8199013342 [Package]; Contains: D8199013340; 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: 2024-03-18
• Device Publish Date: 2024-03-08

Devices Manufactured by SPECIALTY APPLIANCES, LLC

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• 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