K133412 is an FDA 510(k) clearance for the S200, S300. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on January 8, 2015, 427 days after receiving the submission on November 7, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K133412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2013 |
| Decision Date | January 08, 2015 |
| Days to Decision | 427 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |