Crown Kit

GUDID D8199006300

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary

• Primary Device ID: D8199006300
• NIH Device Record Key: ebc8408b-53fb-4d6c-a39d-db6037daf59c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crown Kit
• Version Model Number: 900630
• 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	D8199006300 [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

• D8199007350 - Printed Pre-Formed Left Cantilever 8mm (Single): 2025-02-17
• D8199007360 - Printed Pre-Formed Left Cantilever 10mm (Single): 2025-02-17
• D8199007380 - Printed Pre-Formed Left Cantilever 12mm (Single): 2025-02-17
• D8199007390 - Printed Pre-Formed Left Cantilever 14mm (Single): 2025-02-17
• D8199007400 - Printed Pre-Formed Right Cantilever 8mm (Single): 2025-02-17
• D8199007410 - Printed Pre-Formed Right Cantilever 10mm (Single): 2025-02-17
• D8199007420 - Printed Pre-Formed Right Cantilever 12mm (Single): 2025-02-17
• D8199007430 - Printed Pre-Formed Right Cantilever 14mm (Single): 2025-02-17