The following data is part of a premarket notification filed by 3d Industrial Imaging Co., Ltd. with the FDA for Dentiqair.
| Device ID | K183676 |
| 510k Number | K183676 |
| Device Name: | DentiqAir |
| Classification | System, Image Processing, Radiological |
| Applicant | 3D Industrial Imaging Co., Ltd. Bldg.138, Rm.413, Seoul National University 1 Gwanak-ro Seoul, KR 0882 |
| Contact | Bora Choi |
| Correspondent | Sanglok Lee Wise Company Inc. #1005, 11-19, Gamasan-ro 27a-gil Guro-gu, KR 08301 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-28 |
| Decision Date | 2019-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022900072 | K183676 | 000 |