The following data is part of a premarket notification filed by 3d Industrial Imaging Co., Ltd with the FDA for Dentiqguide.
| Device ID | K180629 |
| 510k Number | K180629 |
| Device Name: | DentiqGuide |
| Classification | System, Image Processing, Radiological |
| Applicant | 3D Industrial Imaging Co., Ltd 413 Institute Of Computer Technology Seoul National University, Daehak-dong Seoul, KR 08826 |
| Contact | Jin Sa 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 | 2018-03-09 |
| Decision Date | 2018-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022900041 | K180629 | 000 |