Renamel® Gingafill 609101

GUDID D7796091010

COSMEDENT, INC.

Dental composite resin

• Primary Device ID: D7796091010
• NIH Device Record Key: 5e8ca8b4-4785-471a-913a-30e4c8c956b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Gingafill
• Version Model Number: 609101
• Catalog Number: 609101
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	D7796091010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854755

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Renamel® Gingafill]

• D7796091050: 609105
• D7796091040: 609104
• D7796091030: 609103
• D7796091020: 609102
• D7796091010: 609101