K142358 is an FDA 510(k) clearance for the Osstell IDx. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Osstell AB (Gothenburg, SE). The FDA issued a Cleared decision on February 19, 2015, 178 days after receiving the submission on August 25, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K142358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2014 |
| Decision Date | February 19, 2015 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKX - Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |