The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for General Cutting Contra Handpiece.
| Device ID | K182999 |
| 510k Number | K182999 |
| Device Name: | General Cutting Contra Handpiece |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | Nakanishi Inc. 700 Shimonhinata Kanuma-shi, JP 322-8666 |
| Contact | Kimihiko Satoh |
| Correspondent | Katie Reneson Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson, TX 75081 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-30 |
| Decision Date | 2019-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7022639830 | K182999 | 000 |
| D7022639820 | K182999 | 000 |
| D7022639810 | K182999 | 000 |