K041718 is an FDA 510(k) clearance for the KELES FACEMASK. This device is classified as a Headgear, Extraoral, Orthodontic (Class II - Special Controls, product code DZB).
Submitted by Great Lakes Orthodontics, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on October 15, 2004, 113 days after receiving the submission on June 24, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.
| 510(k) Number | K041718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2004 |
| Decision Date | October 15, 2004 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZB — Headgear, Extraoral, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5500 |