The following data is part of a premarket notification filed by Mirage Dental Systems with the FDA for Quikseal.
Device ID | K923895 |
510k Number | K923895 |
Device Name: | QUIKSEAL |
Classification | Sealant, Pit And Fissure, And Conditioner |
Applicant | MIRAGE DENTAL SYSTEMS 200 NORTH 6TH ST. Kansas City, KS 66101 |
Contact | Timothy J Sigler |
Correspondent | Timothy J Sigler MIRAGE DENTAL SYSTEMS 200 NORTH 6TH ST. Kansas City, KS 66101 |
Product Code | EBC |
CFR Regulation Number | 872.3765 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-04 |
Decision Date | 1992-12-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUIKSEAL 90658126 not registered Live/Pending |
Graphic Packaging International, LLC 2021-04-20 |
QUIKSEAL 76238414 2533176 Dead/Cancelled |
GLF, Inc. 2001-04-10 |
QUIKSEAL 74309255 1774881 Dead/Cancelled |
CHAMELEON DENTAL PRODUCTS, INC. 1992-08-27 |