The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Pq1.
| Device ID | K023042 |
| 510k Number | K023042 |
| Device Name: | PQ1 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Markus Gee |
| Correspondent | Markus Gee 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 | 2002-09-12 |
| Decision Date | 2002-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205103963 | K023042 | 000 |
| 00883205103673 | K023042 | 000 |
| 00883205103130 | K023042 | 000 |
| 00883205103062 | K023042 | 000 |