The following data is part of a premarket notification filed by Ewoosoft Co., Ltd. with the FDA for Ezdent-i/ E2/ Prora View/ Smart M Viewer.
| Device ID | K211795 |
| 510k Number | K211795 |
| Device Name: | EzDent-i/ E2/ Prora View/ Smart M Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | Ewoosoft 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. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-10 |
| Decision Date | 2021-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800019700227 | K211795 | 000 |