The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for Digital Dental Intra Oral Sensor, Ezsensor Classic, Ezsensor Hd, Hdi-p, Hdi-s.
| Device ID | K153060 |
| 510k Number | K153060 |
| Device Name: | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | RAYENCE CO., LTD 14, SAMSUNG 1-RO, 1-GIL Hwaseong-si, KR 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 | 2015-10-21 |
| Decision Date | 2015-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858475006030 | K153060 | 000 |