PREMISE

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 Premise.

Pre-market Notification Details

• Device ID: K032921
• 510k Number: K032921
• Device Name: PREMISE
• Classification: Material, Tooth Shade, Resin
• Applicant: SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867
• Contact: Colleen Boswell
• Correspondent: Colleen Boswell; SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-22
• Decision Date: 2003-11-13
• Summary: summary