K012673 is an FDA 510(k) clearance for the PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH).
Submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on October 24, 2001, 71 days after receiving the submission on August 14, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K012673 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2001 |
| Decision Date | October 24, 2001 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DYH — Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3750 |