The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultradent Flowable Composite.
| Device ID | K953525 |
| 510k Number | K953525 |
| Device Name: | ULTRADENT FLOWABLE COMPOSITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | L. M. Chatwin |
| Correspondent | L. M. Chatwin 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 | 1995-07-27 |
| Decision Date | 1995-08-28 |