Nsk Nakanishi, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Nsk Nakanishi, Inc.” (first 1996, latest 1999), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 79 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 5 | 5 |
| EBW | Controller, Foot, Handpiece And Cord | 2 | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 2 | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 | 2 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| KMW | Handpiece, Rotary Bone Cutting | 1 | 1 |
Review panels
- Dental (13)
Most recent Nsk Nakanishi, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991701 | MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) | EFB | 1999-08-10 | 83 |
| K991021 | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | ELC | 1999-06-23 | 86 |
| K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | EBW | 1999-06-09 | 79 |
| K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | EKX | 1999-03-24 | 21 |
| K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | EKX | 1999-03-19 | 18 |
| K980162 | MACH-SIGMA HANDPIECE, ULTRAPUSH | EFB | 1998-06-05 | 140 |
| K972924 | SURGIC II IMPLANT CONTROL UNIT | EBW | 1997-10-30 | 83 |
| K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | EGS | 1997-10-08 | 90 |
| K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | EFB | 1997-06-20 | 38 |
| K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | KMW | 1997-04-15 | 29 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nsk Nakanishi, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nsk Nakanishi, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Nsk Nakanishi, Inc.” (first 1996, latest 1999), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nsk Nakanishi, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nsk Nakanishi, Inc. is 79 days.
Which FDA product codes appear under Nsk Nakanishi, Inc.?
The most frequent FDA product codes under this applicant name are EFB (Handpiece, Air-Powered, Dental, 5); EBW (Controller, Foot, Handpiece And Cord, 2); EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 2).
Next steps
- See all 13 Nsk Nakanishi, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFB, Nsk Nakanishi, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.