Renamel NANO +Plus

GUDID D7796005S10

COSMEDENT, INC.

Dental composite resin Dental composite resin

• Primary Device ID: D7796005S10
• NIH Device Record Key: 40b3376a-ab1a-48a1-b4ab-2844215b0140
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel NANO +Plus
• Version Model Number: 6005S10
• 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	D7796005S10 [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: 2020-01-20
• Device Publish Date: 2020-01-10

On-Brand Devices [Renamel NANO +Plus]

• D7796005S20: 6005S20
• D7796005S10: 6005S10
• D7796005C40: 6005C40