The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Permaquik Bonding Primer.
| Device ID | K951583 |
| 510k Number | K951583 |
| Device Name: | PERMAQUIK BONDING PRIMER |
| 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 | 1995-04-06 |
| Decision Date | 1995-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205103697 | K951583 | 000 |