Not currently registered with FDA under this name
Nsk Nakanishi, Inc.
Tochigi-Ken, Japan. Named as applicant on 13 dental 510(k) clearances between 1996 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 131996–1999
- Markets registered in
- 226 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Nsk Nakanishi, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Nsk Nakanishi, Inc. | 13 clearances | 1996–1999 | Below |
| Brazil | ANVISA | Manufacturer | NSK NAKANISHI INC. | 26 | 2004–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Nsk Nakanishi, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Aug 1999 | K991701 | MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) | EFB Dental Air-Powered Handpiece |
| 23 Jun 1999 | K991021 | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | ELC Ultrasonic Scaler |
| 9 Jun 1999 | K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | EBW Handpiece and Cord Foot Controller |
| 24 Mar 1999 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | EKX Ac-Powered Direct Drive Handpiece |
| 19 Mar 1999 | K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | EKX Ac-Powered Direct Drive Handpiece |
| 5 Jun 1998 | K980162 | MACH-SIGMA HANDPIECE, ULTRAPUSH | EFB Dental Air-Powered Handpiece |
| 30 Oct 1997 | K972924 | SURGIC II IMPLANT CONTROL UNIT | EBW Handpiece and Cord Foot Controller |
| 8 Oct 1997 | K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 20 Jun 1997 | K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | EFB Dental Air-Powered Handpiece |
| 15 Apr 1997 | K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | KMW Rotary Bone Cutting Handpiece |
| 24 Sep 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | EFB Dental Air-Powered Handpiece |
| 12 Sep 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 11 Sep 1996 | K962543 | ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU | EFB Dental Air-Powered Handpiece |
Some of these clearances are listed with FDA today by another company: Nakanishi, Inc. (11), Peter Brasseler Holdings, LLC (5), A-dec, Inc. (2), Sybron Dental Specialties (2), DCI International LLC (2), Medline Industries, LP (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.