RENAMEL ESTHETIC RESTORATIVE SYSTEM

Material, Tooth Shade, Resin

COSMEDENT, INC.

The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Renamel Esthetic Restorative System.

Pre-market Notification Details

• Device ID: K854755
• 510k Number: K854755
• Device Name: RENAMEL ESTHETIC RESTORATIVE SYSTEM
• Classification: Material, Tooth Shade, Resin
• Applicant: COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago, IL 60640
• Contact: Michael O'malley
• Correspondent: Michael O'malley; COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago, IL 60640
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-11-27
• Decision Date: 1986-03-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D7796071D30	K854755	000
D779603A350	K854755	000
D7796031WO0	K854755	000
D7796031PO0	K854755	000
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EDEL6091010	K854755	000
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D7796071D40	K854755	000
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D7796071DI0	K854755	000