K122582 is an FDA 510(k) clearance for the DENTAL X-RAY Z70 (W). This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Denterprise International, Inc. (Ormond Beach, US). The FDA issued a Cleared decision on December 7, 2012, 106 days after receiving the submission on August 23, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K122582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2012 |
| Decision Date | December 07, 2012 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EHD - Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |