The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for Mach-sigma Handpiece, Ultrapush.
| Device ID | K980162 |
| 510k Number | K980162 |
| Device Name: | MACH-SIGMA HANDPIECE, ULTRAPUSH |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Contact | Hiroji Sekiguchi |
| Correspondent | Hiroji Sekiguchi NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-06-05 |