The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Modification Of Pq1.
| Device ID | K983668 |
| 510k Number | K983668 |
| Device Name: | MODIFICATION OF PQ1 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Contact | Scott E Moore |
| Correspondent | Scott E Moore ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-19 |
| Decision Date | 1998-11-30 |