The following data is part of a premarket notification filed by Maruchi with the FDA for Endoseal.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ENDOSEAL 79220043 5567702 Live/Registered |
MARUCHI 2017-08-07 |
![]() ENDOSEAL 79124077 4499939 Live/Registered |
MARUCHI 2012-12-07 |
![]() ENDOSEAL 76084450 2475677 Dead/Cancelled |
ULTRADENT PRODUCTS, INC. 2000-06-30 |