K090937 is an FDA 510(k) clearance for the E-STATIS 40 SYSTEM. This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on July 24, 2009, 112 days after receiving the submission on April 3, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K090937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2009 |
| Decision Date | July 24, 2009 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBW - Controller, Foot, Handpiece And Cord |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |