The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Amelogen Plus.
| Device ID | K043119 |
| 510k Number | K043119 |
| Device Name: | AMELOGEN PLUS |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-10 |
| Decision Date | 2004-12-17 |