Renamel® Flowable Microhybrid 7011B1

GUDID D7797011B10

COSMEDENT, INC.

Dental composite resin

• Primary Device ID: D7797011B10
• NIH Device Record Key: 819ca7eb-91e1-4b72-a827-93eb4bfc13a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Flowable Microhybrid
• Version Model Number: 7011B1
• Catalog Number: 7011B1
• 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	D7797011B10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222435
• Premarket Notification: K980298

FDA Product Code

• EBD: Coating, Filling Material, 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® Flowable Microhybrid]

• D779701MWO0: 701MWO
• D779701A350: 701A35
• D7797011MI0: 7011MI
• D7797011D30: 7011D3
• D7797011CO0: 7011CO
• D7797011C40: 7011C4
• D7797011C30: 7011C3
• D7797011C20: 7011C2
• D7797011B30: 7011B3
• D7797011B20: 7011B2
• D7797011B10: 7011B1
• D7797011A40: 7011A4
• D7797011A30: 7011A3
• D7797011A20: 7011A2
• D7797011A10: 7011A1
• D77970110W0: 70110W