K893396 is an FDA 510(k) clearance for the AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on June 23, 1989, 53 days after receiving the submission on May 1, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K893396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1989 |
| Decision Date | June 23, 1989 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DYH — Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3750 |