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 |