K211795 is an FDA 510(k) clearance for the EzDent-i/ E2/ Prora View/ Smart M Viewer. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Ewoosoft Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on October 4, 2021, 116 days after receiving the submission on June 10, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K211795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2021 |
| Decision Date | October 04, 2021 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |