The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultraez Desensitizing Gel.
| Device ID | K061438 |
| 510k Number | K061438 |
| Device Name: | ULTRAEZ DESENSITIZING GEL |
| 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 | No |
| Date Received | 2006-05-24 |
| Decision Date | 2007-06-12 |
| Summary: | summary |