ROC Kit

GUDID D8199006290

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary

• Primary Device ID: D8199006290
• NIH Device Record Key: d607904f-914e-4b63-ba09-fa44abc29345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROC Kit
• Version Model Number: 900629
• 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: true
• 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	D8199006290 [Primary]

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: 2024-04-30
• Device Publish Date: 2024-04-22

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