Renamel® Posterior Body 6101A1

GUDID D7796101A10

COSMEDENT, INC.

Dental composite resin Dental composite resin

• Primary Device ID: D7796101A10
• NIH Device Record Key: 5a481075-a391-42b8-93f2-9852b1ae2d91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Posterior Body
• Version Model Number: 6101A1
• Catalog Number: 6101A1
• 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	D7796101A10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993659

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® Posterior Body]

• D7796102B01: 6102B0
• D7796102A31: 6102A3
• D7796102A21: 6102A2
• D7796102A11: 6102A1
• D7796101B00: 6101B0
• D7796101A30: 6101A3
• D7796101A20: 6101A2
• D7796101A10: 6101A1