The following data is part of a premarket notification filed by Hefei Dentafilm Medical Equipment Co., Ltd with the FDA for Dental Image Plate Scanner, Model Dfc-4t-smart.
| Device ID | K214091 |
| 510k Number | K214091 |
| Device Name: | Dental Image Plate Scanner, Model DFC-4T-SMART |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Hefei DentaFilm Medical Equipment Co., Ltd No. 98 Tangkou Road, Economic And Technological Development Zone Hefei, CN 230601 |
| Contact | Ming Chang Qiu |
| Correspondent | Ming Chang Qiu Hefei DentaFilm Medical Equipment Co., Ltd No. 98 Tangkou Road, Economic And Technological Development Zone Hefei, CN 230601 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-28 |
| Decision Date | 2022-03-02 |