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 |