OPTIBOND

Agent, Tooth Bonding, Resin

KERR CORPORATION (DANBURY)

The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Optibond.

Pre-market Notification Details

• Device ID: K923546
• 510k Number: K923546
• Device Name: OPTIBOND
• Classification: Agent, Tooth Bonding, Resin
• Applicant: KERR CORPORATION (DANBURY) 28200 WICK RD P.O. BOX 455 Romulus, MI 48174
• Contact: Benjamin Weaver
• Correspondent: Benjamin Weaver; KERR CORPORATION (DANBURY) 28200 WICK RD P.O. BOX 455 Romulus, MI 48174
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-16
• Decision Date: 1992-09-29