ROC Kit

GUDID D8199006290

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary 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

• D8199006250 - Upper ROC Kit for Herbst: 2024-04-30
• D8199006260 - Lower ROC Kit for Herbst: 2024-04-30
• D8199006270 - Upper Crown Kit for Herbst: 2024-04-30
• D8199006280 - Lower Crown Kit for Herbst: 2024-04-30
• D8199006290 - ROC Kit: 2024-04-30
• D8199006290 - ROC Kit: 2024-04-30
• D8199006300 - Crown Kit: 2024-04-30
• D8199013170 - OnBrace Kit: 2024-04-30
• D8199013182 - OnBrace Crown UR2 (5/pk): 2024-03-18