Renamel® NANO™ 6001B0

GUDID D7796001B00

COSMEDENT, INC.

Dental composite resin

• Primary Device ID: D7796001B00
• NIH Device Record Key: c4c09b43-32ff-45ce-8ed1-e4e828247c6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® NANO™
• Version Model Number: 6001B0
• Catalog Number: 6001B0
• 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	D7796001B00 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070583

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® NANO™]

• D779600SB30: 600SB3
• D779600A350: 600A35
• D7796002S31: 6002S3
• D7796002MI1: 6002MI
• D7796002LI1: 6002LI
• D7796002D31: 6002D3
• D7796002D21: 6002D2
• D7796002C41: 6002C4
• D7796002C31: 6002C3
• D7796002C21: 6002C2
• D7796002C11: 6002C1
• D7796002B11: 6002B1
• D7796002B01: 6002B0
• D7796002A41: 6002A4
• D7796002A31: 6002A3
• D7796002A21: 6002A2
• D7796002A11: 6002A1
• D7796002351: 600235
• D7796001MI0: 6001MI
• D7796001LI0: 6001LI
• D7796001D30: 6001D3
• D7796001D20: 6001D2
• D7796001C40: 6001C4
• D7796001C30: 6001C3
• D7796001C20: 6001C2
• D7796001C10: 6001C1
• D7796001B10: 6001B1
• D7796001B00: 6001B0
• D7796001A40: 6001A4
• D7796001A30: 6001A3
• D7796001A20: 6001A2
• D7796001A10: 6001A1