The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Flor-opal Varnish White; Models 4503, 4504, 4506, S4505.
| Device ID | K080249 |
| 510k Number | K080249 |
| Device Name: | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 |
| Classification | Varnish, Cavity |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Diane Rogers |
| Correspondent | Diane Rogers ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-01-31 |
| Decision Date | 2008-02-08 |
| Summary: | summary |