CLEARFIL PHOTO CORE

Material, Tooth Shade, Resin

KURARAY CO.

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

Pre-market Notification Details

• Device ID: K882006
• 510k Number: K882006
• Device Name: CLEARFIL PHOTO CORE
• Classification: Material, Tooth Shade, Resin
• Applicant: KURARAY CO. 875 AVENUE OF THE AMERICAS New York, NY 10001
• Contact: Paul Roberts
• Correspondent: Paul Roberts; KURARAY CO. 875 AVENUE OF THE AMERICAS New York, NY 10001
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-05-13
• Decision Date: 1988-06-13