Renamel® Microhybrid ;Renamel® Flowable Microhybrid

Material, Tooth Shade, Resin

Cosmedent, Inc

The following data is part of a premarket notification filed by Cosmedent, Inc with the FDA for Renamel® Microhybrid ;renamel® Flowable Microhybrid.

Pre-market Notification Details

• Device ID: K222435
• 510k Number: K222435
• Device Name: Renamel® Microhybrid ;Renamel® Flowable Microhybrid
• Classification: Material, Tooth Shade, Resin
• Applicant: Cosmedent, Inc 401 N Michigan Ave, Suite 2500 Chicago, IL 60611
• Contact: Gary Chuven
• Correspondent: Gary Chuven; Cosmedent, Inc 401 N Michigan Ave, Suite 2500 Chicago, IL 60611
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-08-12
• Decision Date: 2022-10-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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EDEL6161A30	K222435	000
EDEL6161A40	K222435	000
EDEL6161B00	K222435	000
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