K936151 is an FDA 510(k) clearance for the EXTRAORAL HEADGEAR. This device is classified as a Headgear, Extraoral, Orthodontic (Class II - Special Controls, product code DZB).
Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on August 1, 1994, 217 days after receiving the submission on December 27, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.
| 510(k) Number | K936151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1993 |
| Decision Date | August 01, 1994 |
| Days to Decision | 217 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 |