CONNECT

Resin, Denture, Relining, Repairing, Rebasing

SYBRON DENTAL SPECIALTIES, INC.

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

Pre-market Notification Details

• Device ID: K954689
• 510k Number: K954689
• Device Name: CONNECT
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• 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: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-10-11
• Decision Date: 1995-10-30