The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd. with the FDA for Ezdent-i; E2; Proraview.
| Device ID | K163533 |
| 510k Number | K163533 |
| Device Name: | EzDent-i; E2; ProraView |
| Classification | System, Image Processing, Radiological |
| Applicant | EWOO SOFT CO., LTD. 801-HO, VATECHNETWORKS BLDG 13, SAMSUNG 1-RO 2- GIL Hwaseong-si, KR 18449 |
| Contact | Young Seok Kim |
| Correspondent | Priscilla Chung LK CONSULTING GROUP USA, INC. 800 ROOSEVELT STE 417 Irvine, CA 92620 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-01-12 |
| Summary: | summary |