ENDOSEAL

Resin, Root Canal Filling

MARUCHI

The following data is part of a premarket notification filed by Maruchi with the FDA for Endoseal.

Pre-market Notification Details

• Device ID: K133054
• 510k Number: K133054
• Device Name: ENDOSEAL
• Classification: Resin, Root Canal Filling
• Applicant: MARUCHI 951 STARBUCK ST. UNIT J Fullerton, CA 92833
• Contact: Priscilla Chung
• Correspondent: Priscilla Chung; MARUCHI 951 STARBUCK ST. UNIT J Fullerton, CA 92833
• Product Code: KIF
• CFR Regulation Number: 872.3820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-27
• Decision Date: 2014-05-12
• Summary: summary