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 | K190087 |
| 510k Number | K190087 |
| 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. 1150 Roosevelt, STE 200 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 | 2019-01-17 |
| Decision Date | 2019-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800019700111 | K190087 | 000 |
| 08800019700180 | K190087 | 000 |