The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for Digital Dental Intra Oral Sensor, Ezsensor Soft, Ezsensor Bio.
| Device ID | K143753 |
| 510k Number | K143753 |
| Device Name: | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Rayence Co., Ltd 14, Samsung 1-ro, 1-gil Hwaseong-si, KP 445-170 |
| Contact | Kevin Kim |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-31 |
| Decision Date | 2015-03-10 |
| Summary: | summary |