K952643 is an FDA 510(k) clearance for the RIGHT-ON ADHESIVE BOUDING SYSTEM. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on July 11, 1995, 32 days after receiving the submission on June 9, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K952643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1995 |
| Decision Date | July 11, 1995 |
| Days to Decision | 32 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 |