K891328 is an FDA 510(k) clearance for the PREFORMED TEMPLATE FOR TOOTH POSITIONER. This device is classified as a Positioner, Tooth, Preformed (Class I - General Controls, product code KMY).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on March 31, 1989, 21 days after receiving the submission on March 10, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5525.
| 510(k) Number | K891328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1989 |
| Decision Date | March 31, 1989 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | KMY — Positioner, Tooth, Preformed |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5525 |