The following data is part of a premarket notification filed by The Yoshida Dental Mfg. Co., Ltd. with the FDA for Prexion3d Eclipse.
| Device ID | K122199 |
| 510k Number | K122199 |
| Device Name: | PREXION3D ECLIPSE |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | THE YOSHIDA DENTAL MFG. CO., LTD. 1-14-1 KANDASUDA-CHO FUNAI TOKYO TECHNOLOGY CTR BLDG 10F Chiyoda-ku, Tokyo, JP 101-0041 |
| Contact | Toshimitsu Murakami |
| Correspondent | Toshimitsu Murakami THE YOSHIDA DENTAL MFG. CO., LTD. 1-14-1 KANDASUDA-CHO FUNAI TOKYO TECHNOLOGY CTR BLDG 10F Chiyoda-ku, Tokyo, JP 101-0041 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-24 |
| Decision Date | 2013-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547497757049 | K122199 | 000 |