The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Palmlight.
| Device ID | K003383 |
| 510k Number | K003383 |
| Device Name: | PALMLIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Markus R Gee |
| Correspondent | Markus R Gee ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-31 |
| Decision Date | 2001-02-06 |