Manufacturer registered with FDA
Nakanishi, Inc.
Kanuma, Japan. Lists 11 dental device types with FDA across 2 registered establishments, and holds 37 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 910
- 510(k) clearances
- 372001–2026
- Markets registered in
- 161,511 registrations outside the US
- Establishments
- 2Japan, United States
510(k) clearances per year, 2000–2026
Registered in 16 markets
Where regulators' registries name Nakanishi, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: JapanOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Nakanishi, Inc. | 37 clearances | 2001–2026 | Below |
| Canada | Health Canada | Registration holder | NAKANISHI INC. | 744 | 2002–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Nakanishi Inc.Nakanishi INC. · NAKANISHI INC. · +2 | 224 | 1998–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | NAKANISHI INCNAKANISHI INC. | 199 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Nakanishi Inc.NAKANISHI INC. | 61 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NAKANISHI INC.Nakanishi Inc. | 61 | 2005–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Nakanishi Inc.NAKANISHI INC. · Nakanishi INC. · +2 | 60 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Nakanishi Inc. | 54 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Nakanishi Inc | 45 | 2006–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NAKANISHI INCNAKANISHI INC. | 29 | 2017–2025 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Nakanishi Inc.NAKANISHI INC. | 16 | 2025–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Nakanishi Inc. | 7 | 2024–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Nakanishi Inc.NAKANISHI INC . · Nakanishi Inc | 5 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | NAKANISHI INC,NAKANISHI INC., · Nakanishi INC, | 3 | 2024–2024 | Pure Global AI |
| China | NMPA | Registration holder | 株式会社中西Nakanishi Inc. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NAKANISHI INC. | 1 | 2017–2017 | 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
Devices listed with FDA
What Nakanishi, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | A450LAB450L SUAIR MOTOR HANDPIECE TN-102AK400LAK450L SUAK455L TUALPHA AIR HANDPIECE, ULTRA-PUSH, ALAS450L SUAS455L TUAT450 B2 220 moreAT450 M4AW300LAW450L SUAW455L TUCare3 PlusCare3 Plus C0TYPE 120VCare3 Plus C1TYPE 120VCare3 Plus C1TYPE 230VCare3 Plus C2TYPE 120VCare3 Plus C3TYPE 120VCH45-QDEX-103 M4EX-117EX-203 B2EX-203 M4EX-203C B2EX-203C M4EX-204 M4FM-CL-M4FM-CL-M4-TFX204 M4FX205 B2FX205 M4iCareiProphy AirIS-205 B2/3IS-205 M4KCL-LEDM205M500LG B2M600LG B2M600LG M4M800M800KLM800LM800WLM890KLM890LM890WLM900M900KM900KLM900LM900WM900WLM990KLM990LM990WLMC-E SU B2/MC-E TU B2/3MC-QD SUMC-QD TUMC2-EMU B2MC2-MUMC2-SUML-XT MUML-XT TUMLXT-MUMLXT-SUMLXT-TUN-45SN-45TN-75MN-75SN-75TNL-75MNL-75TNL9000NSK PUSH-BUTTON MIDWEST REPLACEMENTPA2000 SU M4PAE-M B2PAE-M M4PAE-MU B2PAE-S B2PAE-S M4PAE-SU B2PAE-SU MPAE-T B2PAE-T M4PAE-TU B2PAE-TU M4PANA AIR E MPANA SPRAY PlusPANA-MAX SU B2PANA-MAX SU M4PANA-MAX TU B2PANA-MAX TU M4Pana-Max2 M4PAP-MU 5HPAP-MU B2PAP-MU M4PAP-SU 5HPAP-SU B2PAP-SU M4PAP2-MU M4PAP2-SU M4PE-MSPER-KV-PPER-M4-PPER-PTL-PPerio Mate Nozzle TipPHATELUS 45 SUPHATELUS 45 TUPM-B2PM-B2-LPM-B2-SPM-BA-LPM-KV-LPM-KV-SPM-M4PM-M4-LPM-M4-SPM-PTL-LPM-PTL-SPM-WH-LPM-WH-SPMN-HPPMNG-B2-PPMNG-BA-PPMNG-KV-PPMNG-M4-PPMNG-PTL-PPMNG-SR-PPMNG-WH-PPMNW-B2-PPMNW-PTL-PProphy-MateProphy-Mate neoPTL-950PTL-950TiPTL-CDPTL-CL-FV-TPTL-CL-LEDPTL-CL-LED IIIPTL-CRPTL-MSPTL-SDN(W/O FIBER)QD-J B2/B3QD-J M4S-Max M500 | 2008 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | AS2000 B2/3AS2000 M4DA150SLE11E12E14DE15DE30LDE30LD-SE30RD 243 moreE30RD-SE31DE31D-SE32DE32D-SE4E4DE5E6E7E7DE8E8DE9E9DFC-83FC-86Forza V3Forza V3 LEDG1G1-EG1-SG11G12G13G16G2G2-EG21G22G25G26G28G3G3-EG4G4-EG5G6G6-EG61DG62DG65DG66DG67DG68DG7G8G9H-SG1H-SG8H-SG8LH-SG8RM-OC1LM-OC1RM-RE2M-ST1NE134NE149NE171NE214P1P10P11LP11RP1DP20P20-EP20-SP21LP21L-EP21RP21R-EP25LP25L-EP25L-SP25RP25R-EP25R-SP26LP26RP2DP3DP40P41Perio Kit2Powder Handpiece(For Perio use)Powder Handpiece(For Prophy use)Prophy Kit2S1S10S2S20S21LS21RS3S35S75S900S900K LADS900KLS900LS900SLS950S950BLS950KLS950LS950SLS950WLScaler Cord TiSCL1SCL1DSCL2DSCL3SCL3DSCL4DSCL5SCL5DSG1SG10SG11SG12SG14LSG14RSG15ASG15BSG15CSG15DSG16ASG16BSG17SG18LSG18RSG19SG1ASG2LSG2RSG3SG30SG4 | 2008 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | ARK-2ARS-1BB-ECE-TYPE CONTRA ANGLE NAC-EE-TYPE SPEED INCREASER CONTRA ANGLEES-95EX-5EX-5BEX-6EX-6B 139 moreEX-6BMEX-6DEX-6LEX-8EX-ENDO 128FC-78FFB-ECFPB-EFPB-ECFPB-ECMFX15FX20KFX20mFX22FX23FX25FX25KFX50KFX50mFX55mFX57FX57KFX58mFX65FX65KFX75M15M15LM25M25LM65M95M95LMP-ER64N-30UNAC-E16RNAC-ECnano25LSnano95LSNBBW-ENBBW-ECNLZNLZ CDBNLZ E S120NLZ E UNLZ EndoNLZ LVNLZ S120NLZ UNLZ Va2NM-ENM-E64RNM-ECSG20SG20MSG70MSGA-ESGA-E2GSGA-E2SSGA-ESSGL70MSGMS-ER20iSGS-ESGS-E2GSGS-E2SSGS-ESSurgic Pro NON-OPT(120V)Surgic Pro OPT(120V)Surgic Pro OPT(230V)Surgic Pro+ OPT(120V)TEP-E10RTEP-ER10TEQ-E10RTi-ENDOTi-Max Z45Ti10Ti10LATi15Ti15LTi20Ti20LTi25Ti25LTi25LATi35Ti35LTi45Ti45LTi55Ti55LTi57Ti65Ti65LTi65LATi70LTi75Ti85Ti85LTi85LATi95Ti95EXTi95LTi95LAX-SG20LX-SG20MLX10X10LX12X12LX15X15LX20X20LX25X25LX35X35LX55X55LX57X57LX65X65LX70X70LX75X75LX85X85LX95X95EXX95LZ10LZ15LZ25LZ45LZ85LZ95LZ99L | 2008 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | EL400JS120EL400S120ELEC-MATEELM40MFC-78FC-81Multi Pad 2 SETMulti Pad2nano400NE136 74 moreNE161NE179NE188NE210NE278NL400B SET 5 TAKARA BELMONTNL400BSET5PCBNL400BSET7NORACNL400S120NL400S120ENL400SBSET2BELNLX nanoNLX nano S120NLX nano S120ENLZNLZ BF SETNLZ BFB SETNLZ CDBNLZ E S120NLZ E UNLZ EndoNLZ LVNLZ PRONLZ S120NLZ SEL SETNLZ SELB SETNLZ UNLZ Va2SG20SG20MSG50LEDSG50MSG50MSSG50MS MotorSG70MSG80MSGL50MSGL50M MotorSGL70MSGL80MSurgic AP S 120Surgic AP S 230Surgic AP(120V)Surgic IV Implant Control UnitSurgic Pro NON-OPT(120V)Surgic Pro OPT(120V)Surgic Pro OPT(230V)Surgic Pro+ OPT(120V)Surgic Pro2 NON-OPTSurgic Pro2 OPTSurgic XTSurgic XT P12Surgic XT P23Surgic XT Plus 120V LEDSurgic XT Plus 120V N-OPTSurgic XT Plus 120V OPTSurgic XT Plus 230V N-OPTSurgic XT Plus 230V OPTSurgic XT12 w/o HPSurgic XTS120Surgic XTSTT120ERMSSurgic XTSTT120MS w/o HPSurgic XTSTT230ERMSSurgicXT Plus W/O(120V)SurgicXTSTT120ERMSSurgicXTSTT120MS without HandpieceT-Force DA-700Ti-Max NL400Ti-Max NL400MCTI-MAX TIM40TI-MAX TIM40JTIM40SX-SG20LX-SG20ML | 2008 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | ARK-F4RARS-F4REM10MEM10M2EM10M3EM13MEMD MPA 120VEMD120V1EMD120VSEMD230V1 45 moreEMT120V1EMT120V2EMT120V3EMT2120V1EMT2120VSEMT2230VE1EMT230V1ENDO-MATE 2ENDO-MATE 2 NT120EVA-FHANDY-MATEiProphy mobile complete setiProphy mobile MotoriSD-HPiSD120V1MP-FMP-F10RMP-F16RMP-F20RMPA-F10RMPA-F16RMPA-F20RMPA-F4RMPAS-F16RMPAS-F20RMPAS-F4RNAC-F4RNE131NML-F10RNML-F16RNML-F20RNML-F4RPROPHY-MATETASKAL 7TEP-FTEQ-FTW10MTWZ120V1TWZ120V2TWZ120VSViVa 3 S 120VViva MateViva Mate 3Viva Mate 3UVM-F | 2008 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Maker | E-TYPE SPEED REDUCER CONTRA ANGLEFC-78SG20SG20MSG256TL55 STRSG70MSGA-ESGA-E2GSGA-E2SSGA-ES 53 moreSGL70MSGM-E10RISGM-E16RISGM-E20RISGM-E256RISGM-ER16iSGM-ER20iSGM-ER256iSGM-ER32iSGM-ER64iSGMS-ER20iSGO-1SGO-2SGO-3SGO-4SGO-5SGO-6SGO-ESGO2-ESGP-E10RISGP-E16RISGP-E20RISGP-E256RISGP-E32RISGP-E64RISGQ-ER20hSGR-ESGR2-ESGS-ESGS-E2GSGS-E2SSGS-ESSGT-ESGT2-ESurgic Pro NON-OPT(120V)Surgic Pro OPT(120V)Surgic Pro OPT(230V)Surgic Pro+ OPT(120V)Ti-SG20Ti-SG20LTi-SG25LTi-SG65LX-DSG20X-DSG20hX-DSG20LX-DSG20LhX-SG20LX-SG20MLX-SG25LX-SG65X-SG65LX-SG93X-SG93L | 2008 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | E30LD-SE30RD-SE31D-SE32D-SFC-86G1-SH-SG1H-SG8H-SG8LH-SG8R 58 moreM-OC1LM-OC1RM-RE2M-ST1NE214P20-SP25L-SP25R-SSCL1SCL1DSCL2DSCL3SCL3DSCL4DSCL5SCL5DSG1SG10SG11SG12SG14LSG14RSG15ASG15BSG15CSG15DSG16ASG16BSG17SG18LSG18RSG19SG1ASG2LSG2RSG3SG30SG4SG5SG58SG68SG6DSG7DSG8SG8ASG9V10-SVA-SGN-HPSCVarioSurgVarioSurg 4 (120V)VarioSurg 4 w/o FC (120V)VarioSurg-HPSCVS-LED-HPSCVS4-LED-HPSCVSRG OPT (120V)VSRG120V1VSRG120V2VSRG230V1 | 2008 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | FLASH pearlPerio Mate Powder | 2024 |
| AirbrushKOJ · Class 2 | — | Maker | FC-83Perio Kit2Powder Handpiece(For Perio use)Powder Handpiece(For Prophy use)Prophy Kit2Varios Combi Pro2 Basic Set | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2008 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Nakanishi, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Mar 2026 | K260773 | Varios Combi Pro2 | ELC Ultrasonic Scaler |
| 23 Dec 2025 | K254163 | VarioSurg 4 | DZI Powered Bone Drill |
| 19 Sep 2025 | K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | ELC Ultrasonic Scaler |
| 20 Sep 2024 | K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | EFB Dental Air-Powered Handpiece |
| 24 Jun 2024 | K233288 | NLZ Built-In Motor System | EBW Handpiece and Cord Foot Controller |
| 20 Jun 2024 | K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | EBW Handpiece and Cord Foot Controller |
| 25 Apr 2024 | K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | EFB Dental Air-Powered Handpiece |
| 2 Jun 2023 | K230888 | Titanium Turbine | EFB Dental Air-Powered Handpiece |
| 24 May 2023 | K230106 | General Cutting Straight | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 17 Nov 2022 | K222518 | FX Contra | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 21 Jun 2022 | K203791 | Stainless Turbine | EFB Dental Air-Powered Handpiece |
| 19 Aug 2021 | K211584 | Oral Surgery Contra | KMW Rotary Bone Cutting Handpiece |
| 27 Oct 2020 | K202960 | General Cutting Contra Handpiece | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 16 Apr 2019 | K182999 | General Cutting Contra Handpiece | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 19 Jun 2018 | K173905 | Surgic Pro, Surgic Pro+ | EBW Handpiece and Cord Foot Controller |
| 21 Nov 2017 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | KMW Rotary Bone Cutting Handpiece |
| 31 Aug 2017 | K163402 | NLZ Motor System | EBW Handpiece and Cord Foot Controller |
| 15 Aug 2017 | K163483 | PANA SPRAY Plus | EFB Dental Air-Powered Handpiece |
| 11 May 2017 | K163131 | A-dec NLZ Electric Motor System | EBW Handpiece and Cord Foot Controller |
| 12 Sep 2013 | K131578 | IPROPHY MOBILE | EKX Ac-Powered Direct Drive Handpiece |
| 12 Aug 2013 | K131014 | PANA SPRAY PLUS | EFB Dental Air-Powered Handpiece |
| 5 Mar 2013 | K113717 | ULTRASONIC SCALER | ELC Ultrasonic Scaler |
| 28 Feb 2013 | K121901 | TI-MAX Z45 | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 31 Jan 2013 | K113530 | ULTRASONIC SCALER | ELC Ultrasonic Scaler |
| 20 Jun 2012 | K112024 | TI-MAX X450 | EFB Dental Air-Powered Handpiece |
| 5 Mar 2012 | K113655 | TI-MAX X TURBINE | EFB Dental Air-Powered Handpiece |
| 15 Feb 2012 | K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 | EKX Ac-Powered Direct Drive Handpiece |
| 7 Feb 2012 | K112673 | PROPHY-MATE NEO | EFB Dental Air-Powered Handpiece |
| 21 Jan 2009 | K081811 | CARE3 PLUS | EFB Dental Air-Powered Handpiece |
| 10 Jul 2008 | K073678 | VARIOSURG | DZI Powered Bone Drill |
| 18 Apr 2008 | K071447 | VARIOS 75 | ELC Ultrasonic Scaler |
| 1 May 2007 | K062731 | ULTRASONIC SCALER, VARIOS 560 | ELC Ultrasonic Scaler |
| 20 Dec 2005 | K052700 | PANA-SPRAY | EFB Dental Air-Powered Handpiece |
| 26 Mar 2004 | K031421 | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) | ELC Ultrasonic Scaler |
| 17 Oct 2003 | K032395 | PROPHY-MATE | EFB Dental Air-Powered Handpiece |
| 8 Apr 2002 | K020327 | SURGIC IV IMPLANT CONTROL UNIT | EBW Handpiece and Cord Foot Controller |
| 11 Sep 2001 | K011926 | ELEC-MATE E | EBW Handpiece and Cord Foot Controller |
Some of these clearances are listed with FDA today by another company: Peter Brasseler Holdings, LLC (8), DCI International LLC (7), Dentalez, Inc. (2), Hiossen Inc. (1), Paltop Advanced Dental Solutions Inc. (1), A-dec, Inc. (1).
Also lists devices cleared under other names
Nakanishi, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nsk Nakanishi, Inc. (11), J. Morita USA, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jan 2000 | K992648 | ROTARY MASTER | J. Morita USA, Inc. | EBW Handpiece and Cord Foot Controller |
| 23 Jun 1999 | K991021 | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | Nsk Nakanishi, Inc. | ELC Ultrasonic Scaler |
| 9 Jun 1999 | K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | Nsk Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 24 Mar 1999 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | Nsk Nakanishi, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 19 Mar 1999 | K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | Nsk Nakanishi, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 30 Oct 1997 | K972924 | SURGIC II IMPLANT CONTROL UNIT | Nsk Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 8 Oct 1997 | K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | Nsk Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 20 Jun 1997 | K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 15 Apr 1997 | K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Nsk Nakanishi, Inc. | KMW Rotary Bone Cutting Handpiece |
| 24 Sep 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 12 Sep 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 11 Sep 1996 | K962543 | ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NAKANISHI INC.FDA reg. 9611253 | Kanuma Tochigi, Japan | Contract manufacturer, Manufacturer |
| NSK AMERICA CORP.FDA reg. 1422375 | Hoffman Est, IL, United States | Complaint file establishment, Repacker / relabeler |
Other names on FDA records
Nsk America Corp.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030216). 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.