Nakanishi Inc.
Kanuma Tochigi, JP
NAKANISHI INC. appears in FDA device records in Kanuma Tochigi, JP. FDA records list 40 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 40 510(k) clearances for Nakanishi Inc. between 2001 and 2026. The busiest year on record is 2013, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 2 |
| 2012 | 4 |
| 2013 | 5 |
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260773 | Varios Combi Pro2 | ELC | Substantially Equivalent | |
| K254163 | VarioSurg 4 | DZI | Substantially Equivalent | |
| K252662 | UniBur | HBE | Substantially Equivalent | |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | ELC | Substantially Equivalent | |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | EFB | Substantially Equivalent | |
| K233288 | NLZ Built-In Motor System | EBW | Substantially Equivalent | |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | EBW | Substantially Equivalent | |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | EFB | Substantially Equivalent | |
| K230888 | Titanium Turbine | EFB | Substantially Equivalent | |
| K230106 | General Cutting Straight | EGS | Substantially Equivalent | |
| K222518 | FX Contra | EGS | Substantially Equivalent | |
| K203791 | Stainless Turbine | EFB | Substantially Equivalent | |
| K202120 | P300 Attachment | HBE | Substantially Equivalent | |
| K211584 | Oral Surgery Contra | KMW | Substantially Equivalent | |
| K202960 | General Cutting Contra Handpiece | EGS | Substantially Equivalent | |
| K182999 | General Cutting Contra Handpiece | EGS | Substantially Equivalent | |
| K173905 | Surgic Pro, Surgic Pro+ | EBW | Substantially Equivalent | |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | KMW | Substantially Equivalent | |
| K163402 | NLZ Motor System | EBW | Substantially Equivalent | |
| K163483 | PANA SPRAY Plus | EFB | Substantially Equivalent | |
| K163131 | A-dec NLZ Electric Motor System | EBW | Substantially Equivalent | |
| K132264 | PRIMADO2 TOTAL SURGICAL SYSTEM | HBC | Substantially Equivalent | |
| K131578 | IPROPHY MOBILE | EKX | Substantially Equivalent | |
| K113717 | ULTRASONIC SCALER | ELC | Substantially Equivalent | |
| K121901 | TI-MAX Z45 | EGS | Substantially Equivalent | |
| K113530 | ULTRASONIC SCALER | ELC | Substantially Equivalent | |
| K112024 | TI-MAX X450 | EFB | Substantially Equivalent | |
| K113655 | TI-MAX X TURBINE | EFB | Substantially Equivalent | |
| K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 | EKX | Substantially Equivalent | |
| K112673 | PROPHY-MATE NEO | EFB | Substantially Equivalent | |
| K083112 | PRIMADO | HBC | Substantially Equivalent | |
| K081811 | CARE3 PLUS | EFB | Substantially Equivalent | |
| K080722 | PRIMADO SURGICAL DRILL | ERL | Substantially Equivalent | |
| K073678 | VARIOSURG | DZI | Substantially Equivalent | |
| K071447 | VARIOS 75 | ELC | Substantially Equivalent | |
| K062731 | ULTRASONIC SCALER, VARIOS 560 | ELC | Substantially Equivalent | |
| K031421 | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) | ELC | Substantially Equivalent | |
| K032395 | PROPHY-MATE | EFB | Substantially Equivalent | |
| K020327 | SURGIC IV IMPLANT CONTROL UNIT | EBW | Substantially Equivalent | |
| K011926 | ELEC-MATE E | EBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611253 | 3002807687 | NAKANISHI INC. | 700 SHIMOHINATA, Kanuma Tochigi 322-8666 JP | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KOJAirbrush
- GFABlade, Saw, General & Plastic Surgery, Surgical
- EQJBur, Ear, Nose And Throat
- GFFBur, Surgical, General & Plastic Surgery
- EBWController, Foot, Handpiece And Cord
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- EFBHandpiece, Air-Powered, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- KMWHandpiece, Rotary Bone Cutting
- DZEImplant, Endosseous, Root-Form
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- LQYLocator, Root Apex
- HBCMotor, Drill, Electric
- GEYMotor, Surgical Instrument, Ac-Powered
- DWISaw, Electrically Powered
- HABSaw, Powered, And Accessories
- EWQSaw, Surgical, Ent (Electric Or Pneumatic)
- ELCScaler, Ultrasonic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0226-2019 | 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: 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. | Class II | Terminated | |
| Z-0225-2019 | 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 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. | Class II | Terminated | |
| Z-0224-2019 | 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: 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. | Class II | Terminated | |
| Z-0223-2019 | 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: 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. | Class II | Terminated | |
| Z-0222-2019 | 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 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. | Class II | Terminated | |
| Z-0221-2019 | 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 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. | Class II | Terminated | |
| Z-0220-2019 | 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 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. | Class II | Terminated | |
| Z-0219-2019 | 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. | Class II | Terminated | |
| Z-2674-2016 | 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 intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth. | 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. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused. | Class II | Terminated | |
| Z-2673-2016 | 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 to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation. | 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. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused. | Class II | Terminated | |
| Z-2672-2016 | 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 the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing). | 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. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain