K943068 is an FDA 510(k) clearance for the MAGNEFORCE. This device is classified as a Spring, Orthodontic (Class I - General Controls, product code ECO).
Submitted by Ormco Corp. (Glendora, US). The FDA issued a Cleared decision on August 17, 1994, 50 days after receiving the submission on June 28, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K943068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 1994 |
| Decision Date | August 17, 1994 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ECO — Spring, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |