The following data is part of a premarket notification filed by Discus Dental, Llc with the FDA for Simpliseal.
Device ID | K093208 |
510k Number | K093208 |
Device Name: | SIMPLISEAL |
Classification | Resin, Root Canal Filling |
Applicant | DISCUS DENTAL, LLC 8550 HIGUERA ST. Culver City, CA 90232 |
Contact | Clark D Vonahsen |
Correspondent | Clark D Vonahsen DISCUS DENTAL, LLC 8550 HIGUERA ST. Culver City, CA 90232 |
Product Code | KIF |
CFR Regulation Number | 872.3820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-13 |
Decision Date | 2010-02-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SIMPLISEAL 77107590 3423737 Live/Registered |
ORMCO CORPORATION 2007-02-14 |
SIMPLISEAL 76701832 3875242 Dead/Cancelled |
Liquid Molding Systems, Inc. 2010-03-02 |