The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for Digital Dental Intra Oral Sensor, Hdi 2000, Hdi 2000a.
| Device ID | K140060 |
| 510k Number | K140060 |
| Device Name: | DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | RAYENCE CO., LTD 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Contact | Dave Kim |
| Correspondent | Dave Kim RAYENCE CO., LTD 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-10 |
| Decision Date | 2014-05-13 |
| Summary: | summary |