Renamel® NANO™ +plus 6006C4

GUDID D7796006C41

COSMEDENT, INC.

Dental composite resin

• Primary Device ID: D7796006C41
• NIH Device Record Key: 752f4483-af46-4c2c-a55f-72b545da51c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® NANO™ +plus
• Version Model Number: 6006C4
• Catalog Number: 6006C4
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• Device Count: 10
• 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: true
• 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	D7796006C40 [Unit of Use]
HIBCC	D7796006C41 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163480

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2018-12-10
• Device Publish Date: 2018-11-09

On-Brand Devices [Renamel® NANO™ +plus]

• D7796006WI1: 6006WI
• D7796006S31: 6006S3
• D7796006S21: 6006S2
• D7796006S11: 6006S1
• D7796006MI1: 6006MI
• D7796006LI1: 6006LI
• D7796006D31: 6006D3
• D7796006D21: 6006D2
• D7796006C41: 6006C4
• D7796006C31: 6006C3
• D7796006C21: 6006C2
• D7796006C11: 6006C1
• D7796006B21: 6006B2
• D7796006B11: 6006B1
• D7796006B01: 6006B0
• D7796006A41: 6006A4
• D7796006A31: 6006A3
• D7796006A21: 6006A2
• D7796006A11: 6006A1
• D7796006351: 600635
• D7796005WI0: 6005WI
• D7796005S30: 6005S3
• D7796005MI0: 6005MI
• D7796005LI0: 6005LI
• D7796005D30: 6005D3
• D7796005D20: 6005D2
• D7796005C30: 6005C3
• D7796005C20: 6005C2
• D7796005C10: 6005C1
• D7796005B20: 6005B2
• D7796005B10: 6005B1
• D7796005B00: 6005B0
• D7796005A40: 6005A4
• D7796005A30: 6005A3
• D7796005A20: 6005A2
• D7796005A10: 6005A1
• D7796005350: 600535