Data / Medical devices / Japan / Nakanishi Inc.
Nakanishi Inc.: FDA-registered device maker in Kanuma Tochigi, Japan, 53 510(k) clearances
Nakanishi Inc. is registered with the FDA (registration 9611253) in Kanuma Tochigi, Japan. It lists 23 device types. The FDA files 53 510(k) clearances under its listings, the newest dated March 10, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611253
- FEI number
- 3002807687
- Address
- 700 Shimohinata, Kanuma Tochigi, Japan, 322-8666
- Owner or operator
- NAKANISHI INC. (8030216)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 25, 2006
- Registered through
- 2026
- Brand names listed
- A450L, AB450L SU, AIR MOTOR HANDPIECE TN-102, AK400L, AK450L SU, AK455L TU, ALPHA AIR HANDPIECE, ULTRA-PUSH, AL, ARK-2 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 10, 2026 | K260773 | Varios Combi Pro2 | ELC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| December 23, 2025 | K254163 | VarioSurg 4 | DZI | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| September 19, 2025 | K252662 | UniBur | HBE | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| September 19, 2025 | K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | ELC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| September 20, 2024 | K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| June 24, 2024 | K233288 | NLZ Built-In Motor System | EBW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| June 20, 2024 | K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | EBW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| April 25, 2024 | K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| June 2, 2023 | K230888 | Titanium Turbine | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| May 24, 2023 | K230106 | General Cutting Straight | EGS | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| November 17, 2022 | K222518 | FX Contra | EGS | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| June 21, 2022 | K203791 | Stainless Turbine | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| October 22, 2021 | K202120 | P300 Attachment | HBE | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| August 19, 2021 | K211584 | Oral Surgery Contra | KMW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| October 27, 2020 | K202960 | General Cutting Contra Handpiece | EGS | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| April 16, 2019 | K182999 | General Cutting Contra Handpiece | EGS | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| June 19, 2018 | K173905 | Surgic Pro, Surgic Pro+ | EBW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| November 21, 2017 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | KMW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| August 31, 2017 | K163402 | NLZ Motor System | EBW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| August 15, 2017 | K163483 | PANA SPRAY Plus | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| May 11, 2017 | K163131 | A-dec NLZ Electric Motor System | EBW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| December 17, 2013 | K132264 | PRIMADO2 TOTAL SURGICAL SYSTEM | HBC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| September 12, 2013 | K131578 | IPROPHY MOBILE | EKX | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| March 5, 2013 | K113717 | ULTRASONIC SCALER | ELC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| February 28, 2013 | K121901 | TI-MAX Z45 | EGS | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| January 31, 2013 | K113530 | ULTRASONIC SCALER | ELC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| June 20, 2012 | K112024 | TI-MAX X450 | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| March 5, 2012 | K113655 | TI-MAX X TURBINE | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| February 15, 2012 | K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 | EKX | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| February 7, 2012 | K112673 | PROPHY-MATE NEO | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| April 29, 2009 | K083112 | PRIMADO | HBC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| January 21, 2009 | K081811 | CARE3 PLUS | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| September 17, 2008 | K080722 | PRIMADO SURGICAL DRILL | ERL | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| July 10, 2008 | K073678 | VARIOSURG | DZI | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| April 18, 2008 | K071447 | VARIOS 75 | ELC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| May 1, 2007 | K062731 | ULTRASONIC SCALER, VARIOS 560 | ELC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| January 24, 2006 | K053235 | NSK PRECISION APEX LOCATOR (PAL) | LQY | Substantially Equivalent | Medicsense USA | accessdata.fda.gov |
| March 26, 2004 | K031421 | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) | ELC | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| October 17, 2003 | K032395 | PROPHY-MATE | EFB | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| April 8, 2002 | K020327 | SURGIC IV IMPLANT CONTROL UNIT | EBW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| September 11, 2001 | K011926 | ELEC-MATE E | EBW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| January 31, 2000 | K992648 | ROTARY MASTER | EBW | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| June 23, 1999 | K991021 | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | ELC | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| June 9, 1999 | K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | EBW | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| March 24, 1999 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | EKX | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| March 19, 1999 | K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | EKX | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| October 30, 1997 | K972924 | SURGIC II IMPLANT CONTROL UNIT | EBW | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| October 8, 1997 | K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | EGS | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| June 20, 1997 | K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | EFB | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| April 15, 1997 | K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | KMW | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| September 24, 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | EFB | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| September 12, 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | EGS | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| September 11, 1996 | K962543 | ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU | EFB | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 1, 2018 | 80713 | Class II | Terminated | Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals. | accessdata.fda.gov |
| July 8, 2016 | 74666 | Class II | Terminated | Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and t | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. | accessdata.fda.gov |
Compare with other makers
- All makers of Saw, Surgical, Ent (Electric Or Pneumatic)
- All makers of Scaler, Ultrasonic
- All makers of Drill, Bone, Powered
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- All makers of Controller, Foot, Handpiece And Cord
Updated March 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.