The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd. with the FDA for Ezdent-i / E2 / Prora View.
| Device ID | K172364 |
| 510k Number | K172364 |
| Device Name: | EzDent-i / E2 / Prora View |
| 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. 690 Roosevelt Irvine, CA 92620 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-04 |
| Decision Date | 2017-08-22 |
| Summary: | summary |