K170066 is an FDA 510(k) clearance for the Green16/Green18 (Model: PHT-65LHS). This device is classified as a X-ray, Tomography, Computed, Dental (Class II - Special Controls, product code OAS).
Submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on June 16, 2017, 158 days after receiving the submission on January 9, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750. Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth..
| 510(k) Number | K170066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2017 |
| Decision Date | June 16, 2017 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OAS — X-ray, Tomography, Computed, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |
| Definition | Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth. |