K073319 is an FDA 510(k) clearance for the STATMATIC 31 HANDPIECE MAINTENANCE UNIT. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on February 4, 2008, 70 days after receiving the submission on November 26, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K073319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2007 |
| Decision Date | February 04, 2008 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EFB - Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |