The following data is part of a premarket notification filed by The Yoshida Dental Mfg. Co., Ltd. with the FDA for Prexion 3d.
| Device ID | K120948 |
| 510k Number | K120948 |
| Device Name: | PREXION 3D |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | THE YOSHIDA DENTAL MFG. CO., LTD. 1-3-6 KOTOBASHI, SUMIDA-KU Tokyo, JP 130-8516 |
| Contact | Hidenori Watanabe |
| Correspondent | Hidenori Watanabe THE YOSHIDA DENTAL MFG. CO., LTD. 1-3-6 KOTOBASHI, SUMIDA-KU Tokyo, JP 130-8516 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-29 |
| Decision Date | 2012-12-21 |
| Summary: | summary |