K071891 is an FDA 510(k) clearance for the STATIS DENTAL HANDPIECES. 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 September 13, 2007, 66 days after receiving the submission on July 9, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K071891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2007 |
| Decision Date | September 13, 2007 |
| Days to Decision | 66 days |
| Submission Type | Abbreviated |
| 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 |