K000189 is an FDA 510(k) clearance for the PQ1. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 11, 2000, 111 days after receiving the submission on January 21, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K000189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2000 |
| Decision Date | May 11, 2000 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |