CosmeCore 6227A2

GUDID D7796227A20

COSMEDENT, INC.

Dental composite resin

• Primary Device ID: D7796227A20
• NIH Device Record Key: 33f6e39f-f8cc-487b-8dbf-2fdf5017b244
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CosmeCore
• Version Model Number: 6227A2
• Catalog Number: 6227A2
• 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	D7796227A20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040994

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 [CosmeCore]

• D7796227A20: 6227A2
• D77962270W0: 62270W
• D77962270B0: 62270B
• D7796221A20: 6221A2
• D77962210W0: 62210W
• D77962210B0: 62210B