Company ยท JP
Nakanishi, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2026. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (2 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 11 |
| KMW | Handpiece, Rotary Bone Cutting | 10 |
| ELC | Scaler, Ultrasonic | 9 |
| EBW | Controller, Foot, Handpiece And Cord | 7 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 5 |
| DZI | Drill, Bone, Powered | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 |
| HBC | Motor, Drill, Electric | 2 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2026 | K260773 | Varios Combi Pro2 Nakanishi, Inc., JP | ELC |
| Dec 23, 2025 | K254163 | VarioSurg 4 Nakanishi, Inc., JP | DZI |
| Sep 19, 2025 | K252662 | UniBur Nakanishi, Inc., JP | HBE |
| Sep 19, 2025 | K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S Nakanishi, Inc., JP | ELC |
| Sep 20, 2024 | K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) Nakanishi, Inc., JP | EFB |
| Jun 24, 2024 | K233288 | NLZ Built-In Motor System Nakanishi, Inc., JP | EBW |
| Jun 20, 2024 | K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) Nakanishi, Inc., JP | EBW |
| Apr 25, 2024 | K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) Nakanishi, Inc., JP | EFB |
| Jun 2, 2023 | K230888 | Titanium Turbine Nakanishi, Inc., JP | EFB |
| May 24, 2023 | K230106 | General Cutting Straight Nakanishi, Inc., JP | EGS |
| Nov 17, 2022 | K222518 | FX Contra Nakanishi, Inc., JP | EGS |
| Jun 21, 2022 | K203791 | Stainless Turbine Nakanishi, Inc., JP | EFB |
| Oct 22, 2021 | K202120 | P300 Attachment Nakanishi, Inc., JP | HBE |
| Aug 19, 2021 | K211584 | Oral Surgery Contra Nakanishi, Inc., JP | KMW |
| Oct 27, 2020 | K202960 | General Cutting Contra Handpiece Nakanishi, Inc., JP | EGS |
| Apr 16, 2019 | K182999 | General Cutting Contra Handpiece Nakanishi, Inc., JP | EGS |
| Jun 19, 2018 | K173905 | Surgic Pro, Surgic Pro+ Nakanishi, Inc., JP | EBW |
| Nov 21, 2017 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece Nakanishi, Inc., JP | KMW |
| Aug 31, 2017 | K163402 | NLZ Motor System Nakanishi, Inc., JP | EBW |
| Aug 15, 2017 | K163483 | PANA SPRAY Plus Nakanishi, Inc., JP | EFB |
| May 11, 2017 | K163131 | A-dec NLZ Electric Motor System Nakanishi, Inc., JP | EBW |
| Dec 17, 2013 | K132264 | PRIMADO2 TOTAL SURGICAL SYSTEM Nakanishi, Inc. | HBC |
| Sep 12, 2013 | K131578 | IPROPHY MOBILE Nakanishi, Inc. | EKX |
| Mar 5, 2013 | K113717 | ULTRASONIC SCALER Nakanishi, Inc. | ELC |
| Feb 28, 2013 | K121901 | TI-MAX Z45 Nakanishi, Inc., JP | EGS |
| Jan 31, 2013 | K113530 | ULTRASONIC SCALER Nakanishi, Inc. | ELC |
| Jun 20, 2012 | K112024 | TI-MAX X450 Nakanishi, Inc. | EFB |
| Mar 5, 2012 | K113655 | TI-MAX X TURBINE Nakanishi, Inc. | EFB |
| Feb 15, 2012 | K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 Nakanishi, Inc. | EKX |
| Feb 7, 2012 | K112673 | PROPHY-MATE NEO Nakanishi, Inc. | EFB |
| Apr 29, 2009 | K083112 | PRIMADO Nakanishi, Inc. | HBC |
| Jan 21, 2009 | K081811 | CARE3 PLUS Nakanishi, Inc. | EFB |
| Sep 17, 2008 | K080722 | PRIMADO SURGICAL DRILL Nakanishi, Inc. | ERL |
| Jul 10, 2008 | K073678 | VARIOSURG Nakanishi, Inc. | DZI |
| Apr 18, 2008 | K071447 | VARIOS 75 Nakanishi, Inc., JP | ELC |
| May 1, 2007 | K062731 | ULTRASONIC SCALER, VARIOS 560 Nakanishi, Inc., JP | ELC |
| Mar 26, 2004 | K031421 | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) Nakanishi, Inc. | ELC |
| Oct 17, 2003 | K032395 | PROPHY-MATE Nakanishi, Inc., JP | EFB |
| Apr 8, 2002 | K020327 | SURGIC IV IMPLANT CONTROL UNIT Nakanishi, Inc., JP | EBW |
| Sep 11, 2001 | K011926 | ELEC-MATE E Nakanishi, Inc., JP | EBW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2018 | Nakanishi Inc. Micro Surgery Handpiece SGA, Model SGA-E2S Order Code:
H265, Manufactured by: Nakanishi Inc.
The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use Terminated |
KMW | K171155 |
| Oct 24, 2018 | Nakanishi Inc. Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc.
The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant us Terminated |
KMW | K171155 |
| Oct 24, 2018 | Nakanishi Inc. Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc
The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use Terminated |
KMW | K171155 |
| Oct 24, 2018 | Nakanishi Inc. Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc.
The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use Terminated |
KMW | K171155 |
| Oct 24, 2018 | Nakanishi Inc. Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc.
The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping t Terminated |
KMW | K171155 |
| Oct 24, 2018 | Nakanishi Inc. Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc.
The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the Terminated |
KMW | K171155 |
| Oct 24, 2018 | Nakanishi Inc. Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc.
The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the Terminated |
KMW | K171155 |
| Oct 24, 2018 | Nakanishi Inc. 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 Terminated |
KMW | K171155 |
| Jul 8, 2016 | Nakanishi Inc. Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico)
The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the Terminated |
EFB | K962543 |
| Jul 8, 2016 | Nakanishi Inc. Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light)
The intended use of the tips is based on the parent device. For the VarioSurg, in addition Terminated |
ELC | K073678 |
| Jul 8, 2016 | Nakanishi Inc. 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 ult Terminated |
ELC | K031421 |