HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL

Crown And Bridge, Temporary, Resin

COSMEDENT, INC.

The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for High Viscosity Composite Temporary (provisional) Material.

Pre-market Notification Details

• Device ID: K980799
• 510k Number: K980799
• Device Name: HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
• Classification: Crown And Bridge, Temporary, 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: EBG
• CFR Regulation Number: 872.3770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-03-02
• Decision Date: 1998-10-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D779505HS30	K980799	000
D779505HA20	K980799	000
D779505HA10	K980799	000