K942492 is an FDA 510(k) clearance for the ADJUSTABLE BITE CORRECTOR. This device is classified as a Spring, Orthodontic (Class I - General Controls, product code ECO).
Submitted by Orthoplus, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on July 13, 1994, 49 days after receiving the submission on May 25, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K942492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1994 |
| Decision Date | July 13, 1994 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ECO — Spring, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |