The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Flor-opal Varnish, Models Up 4500/ Up 4501/ Up 4502.
| Device ID | K051750 |
| 510k Number | K051750 |
| Device Name: | FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 |
| Classification | Varnish, Cavity |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Tammy Lavery |
| Correspondent | Tammy Lavery ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-06-29 |
| Decision Date | 2005-09-19 |
| Summary: | summary |