CLEARFIL SA PRIMER

Agent, Tooth Bonding, Resin

KURARAY MEDICAL INC.

The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Sa Primer.

Pre-market Notification Details

• Device ID: K021427
• 510k Number: K021427
• Device Name: CLEARFIL SA PRIMER
• Classification: Agent, Tooth Bonding, Resin
• Applicant: KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022
• Contact: Masaya Sasaki
• Correspondent: Masaya Sasaki; KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-03
• Decision Date: 2002-06-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EKUR000066KA1	K021427	000