The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Permalute Composite Luting/restorative Resin System.
| Device ID | K960696 |
| 510k Number | K960696 |
| Device Name: | PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM |
| 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 | 1996-02-20 |
| Decision Date | 1996-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205106841 | K960696 | 000 |
| 00883205106834 | K960696 | 000 |
| 00883205106827 | K960696 | 000 |
| 00883205106810 | K960696 | 000 |
| 00883205106230 | K960696 | 000 |
| 00883205106223 | K960696 | 000 |