CLEARFIL SE BOND

Agent, Tooth Bonding, Resin

KURARAY CO.

The following data is part of a premarket notification filed by Kuraray Co. with the FDA for Clearfil Se Bond.

Pre-market Notification Details

• Device ID: K990040
• 510k Number: K990040
• Device Name: CLEARFIL SE BOND
• Classification: Agent, Tooth Bonding, Resin
• Applicant: KURARAY CO. 200 PARK AVE. New York, NY 10166
• Contact: Koji Fujita
• Correspondent: Koji Fujita; KURARAY CO. 200 PARK AVE. New York, NY 10166
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-01-06
• Decision Date: 1999-02-04
• Summary: summary