K000358 is an FDA 510(k) clearance for the MULTI ADJUSTABLE FACE MASK. This device is classified as a Headgear, Extraoral, Orthodontic (Class II - Special Controls, product code DZB).
Submitted by Ortho Technology (Tampa, US). The FDA issued a Cleared decision on June 9, 2000, 126 days after receiving the submission on February 4, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.
| 510(k) Number | K000358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2000 |
| Decision Date | June 09, 2000 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZB — Headgear, Extraoral, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5500 |