The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Permagen F/dc.
| Device ID | K943373 |
| 510k Number | K943373 |
| Device Name: | PERMAGEN F/DC |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1994-08-23 |