The following data is part of a premarket notification filed by Yamahachi Dental Mfg., Co. with the FDA for Yamahachi Pink Cad/cam Disk.
| Device ID | K172683 |
| 510k Number | K172683 |
| Device Name: | Yamahachi Pink CAD/CAM Disk |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Yamahachi Dental Mfg., Co. 54-1, Ochigara Nishiura-Cho Gamamori-city, JP 443-0105 |
| Contact | Shogo Muramatsu |
| Correspondent | Joyce St. Germaine Denterprise International, Inc./510k FDA Consulting 100 East Granada Blvd. Ormond Beach, FL 32176 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-06 |
| Decision Date | 2018-01-16 |
| Summary: | summary |