The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultra-etch Stat.
| Device ID | K965060 |
| 510k Number | K965060 |
| Device Name: | ULTRA-ETCH STAT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Chester Mcoy |
| Correspondent | Chester Mcoy ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-18 |
| Decision Date | 1997-01-31 |