The following data is part of a premarket notification filed by Dentium Co., Ltd (ict Branch) with the FDA for Intraoral Sensor.
| Device ID | K201247 |
| 510k Number | K201247 |
| Device Name: | Intraoral Sensor |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Dentium Co., Ltd (ICT Branch) 76, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-si, KR 16229 |
| Contact | Sangwoo Lee |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St. Ste 200, V111 Houston, TX 77054 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-11 |
| Decision Date | 2020-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809460309867 | K201247 | 000 |
| 08809460309850 | K201247 | 000 |