DURAFLEX

Resin, Denture, Relining, Repairing, Rebasing

COSMETIC DENTAL MATERIALS INC

The following data is part of a premarket notification filed by Cosmetic Dental Materials Inc with the FDA for Duraflex.

Pre-market Notification Details

• Device ID: K063626
• 510k Number: K063626
• Device Name: DURAFLEX
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: COSMETIC DENTAL MATERIALS INC 812 WATER ST. N.E. Albany, OR 97321
• Contact: Robert Bowers
• Correspondent: Robert Bowers; COSMETIC DENTAL MATERIALS INC 812 WATER ST. N.E. Albany, OR 97321
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-12-06
• Decision Date: 2007-02-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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