OPTIGUARD

Material, Tooth Shade, Resin

SYBRON DENTAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Optiguard.

Pre-market Notification Details

• Device ID: K945539
• 510k Number: K945539
• Device Name: OPTIGUARD
• Classification: Material, Tooth Shade, Resin
• Applicant: SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740
• Contact: Jeffrey A Anderson
• Correspondent: Jeffrey A Anderson; SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-14
• Decision Date: 1994-12-29