The following data is part of a premarket notification filed by The Yoshida Dental Mfg. Co., Ltd. with the FDA for Panoura 18s.
| Device ID | K111231 |
| 510k Number | K111231 |
| Device Name: | PANOURA 18S |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | THE YOSHIDA DENTAL MFG. CO., LTD. 4-1-17 HONGO, BUNKYO-KU Tokyo, JP 113-0033 |
| Contact | Fumiaki Kanai |
| Correspondent | Fumiaki Kanai THE YOSHIDA DENTAL MFG. CO., LTD. 4-1-17 HONGO, BUNKYO-KU Tokyo, JP 113-0033 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-07-13 |
| Summary: | summary |