K843344 is an FDA 510(k) clearance for the ACTIVE VERTICAL CORRECTOR ACTIVE BITE. This device is classified as a Spring, Orthodontic (Class I - General Controls, product code ECO).
Submitted by Active Vertical Correctors, Inc. (Fort Wayne, US). The FDA issued a Cleared decision on December 3, 1984, 98 days after receiving the submission on August 27, 1984.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K843344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1984 |
| Decision Date | December 03, 1984 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ECO — Spring, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |