The following data is part of a premarket notification filed by The Yoshida Dental Mfg. Co., Ltd. with the FDA for Finecube Dental Ct.
| Device ID | K063622 |
| 510k Number | K063622 |
| Device Name: | FINECUBE DENTAL CT |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | THE YOSHIDA DENTAL MFG. CO., LTD. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm THE YOSHIDA DENTAL MFG. CO., LTD. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-05 |
| Decision Date | 2007-02-08 |
| Summary: | summary |