Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1422375

FEI Number

1000139790

Entity Name

NSK AMERICA CORP.

City/State/Country

Hoffman Est, IL, US

Establishment Address

1800 Global Parkway, Hoffman Est, IL 60192, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

NAKANISHI INC. (Owner Number: 8030216)

Owner / Operator Contact Address

700 Shimohinata, Kanuma, JP-09 322-8666, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K962542

PMA Number

N/A

All Registered Proprietary Names

SGO-2 SGM-E256RI SGO-3 SGP-E32RI SG256TL55 STR SGP-E256RI X-DSG20 Ti-SG20L X-SG65 SGO-5 SGQ-ER20h SGM-ER64i SGO-6 SGT-E X-DSG20h Ti-SG25L X-DSG20Lh SGM-ER32i SGO-1 X-DSG20L Ti-SG20 SGR2-E SGO-4 SGP-E20RI SGMS-ER20i SGO-E SGP-E10RI SGP-E64RI SGM-E20RI SGO2-E SGT2-E X-SG65L SGM-ER256i SGR-E SGP-E16RI SGM-ER20i Ti-SG65L E-TYPE SPEED REDUCER CONTRA ANGLE SGM-E10RI SGM-E16RI SGM-ER16i S21R S950KL S900L S900 V-U25 S20 V-U15 S900KL S950SL S2 S75 S21L S950 SONIC SCALER WITH FIBER OPTIC S900SL V-U20 S950WL S950L V-U35 S3 S900K LAD S35 V-U30 S950BL AS2000 B2/3 S10 AS2000 M4 S1 Z890L Z990KL Z990WL Z micro KL Z890WL Z890KL Z micro Z990L Primado VA370NA VA370ADNA Forza V3 VA370LUXADNA VA370 SY-LUX-HP VA370LUXNA Forza V3 LED VA370 Lux Varios 370 PTL-CL-LED Pana-Max2 M4 FM-CL-M4-T S-Max pico WLED M900WL M800L QD-J M4 M800 S-Max pico KL M900L KCL-LED FM-CL-M4 PTL-CL-FV-T M800KL M900K QD-J B2/B3 S-Max pico SL M900W S-Max pico M800WL M900 M900KL PTL-CL-LED III S-Max pico BLED PAP2-MU M4 PAP2-SU M4 Primado iSD-HP EM10M3 iSD120V1 SG70M Surgic Pro+ OPT(120V) X-SG20L Surgic Pro OPT(230V) Surgic Pro OPT(120V) Surgic Pro NON-OPT(120V) FC-78 X-SG20ML SG20M SG20 SGL70M X-SG25L X-SG93 X-SG93L Primado Primado Surgical System Primado Bur VA170S11 VA170LUXS10 VA170LUXS11 Prophy-Mate PM-KV-S PM-B2-L PM-KV-L PM-PTL-L PM-BA-L PM-WH-L PM-B2-S PM-B2 PM-WH-S PM-PTL-S PM-M4-S PM-M4 PM-M4-L PMNG-BA-P PMN-HP PMNG-SR-P PMNG-B2-P PMNW-PTL-P PMNG-KV-P PMNG-PTL-P Prophy-Mate neo PMNW-B2-P PMNG-WH-P PMNG-M4-P PRIMADO SURGICAL SYSTEM NE171 VA560LUX230S VA560 230S VA560 120S ULTRASONIC SCALER VARIOS 560 VA560LUX120S Multi Pad2 NLZ BF SET NLZ SEL SET Multi Pad 2 SET NLZ SELB SET NLZ PRO NLZ BFB SET EX-5B FX65K FX50m X65 M65 X65L FX65 FX50K Primado iProphy mobile Motor iProphy mobile complete set Z95L Z99L Ti-Max Z45 Z45L PANA SPRAY Plus VarioSurg 4 (120V) FC-86 VarioSurg 4 w/o FC (120V) VS4-LED-HPSC FX204 M4 M205 Ti55 X35 Ti95LA E-TYPE SPEED INCREASER CONTRA ANGLE Ti85LA X20 Ti85L X95EX X10 Ti35 Ti95 Ti15 Ti85 Ti55L Ti15L Ti45L X75L X70 X10L FPB-E X55L Ti25LA M65 X70L Ti95EX Ti75 Ti95L ES-95 Ti10 X75 Ti70L Ti25L Ti25 Ti20L Ti57 X35L X57L X57 X55 Ti10LA Ti45 Ti35L Ti20 PER-PTL-P Perio Mate Nozzle Tip PER-KV-P PER-M4-P SGL80M Surgic Pro2 OPT Surgic Pro2 NON-OPT FC-81 SG80M VA150 VA350S230V Varios VA350LUX120 NE149 VA350S120V DA150SL Varios 350 VA150LUX VA150LUX BEL - NA MPA-F20R EM13M EMD120VS MPA-F10R EMT2230VE1 EMT120V1 EMT2120VS TWZ120V1 TWZ120VS NML-F4R NML-F16R EMT120V2 EMD230V1 ENDO-MATE 2 NT120 TWZ120V2 MP-F10R TEP-F NE131 MPAS-F20R PROPHY-MATE EMD120V1 MP-F20R NAC-F4R MPA-F4R EVA-F EMT2120V1 EMT230V1 MP-F16R ARS-F4R VM-F MPAS-F4R TEQ-F ENDO-MATE 2 NML-F10R EM10M2 EMD MPA 120V MPAS-F16R NML-F20R MP-F TASKAL 7 EMT120V3 MPA-F16R TW10M EM10M ARK-F4R Surgic XT SGS-E SGS-ES SGA-ES SGA-E2S SGS-E2G SGS-E2S SGA-E2G SGA-E Ti-Max X600WLED Z800STL Ti-Max X500SL Z900MWL Z800WL Ti-Max X700KL Z800WHL Ti-Max X500KL Z900WL Ti-Max X600 NL9000 Z900KL Ti-Max X700SL Z900L Ti-Max X500WLED Z800MWL Ti-Max X700 Z800L Ti-Max X600SL Ti-Max X600BLED Ti-Max Z Turbine Z800KL Ti-Max X600WHL Ti-Max X Turbine Z900WHL Ti-Max X600KL Ti-Max X500L Z900STL Ti-Max X600L Ti-Max X700L NLX nano S120E NE188 Ti-Max NL400MC TIM40S NLX nano NL400S120 NE210 NL400S120E NL400SBSET2BEL NL400B SET 5 TAKARA BELMONT NL400BSET7NORAC TI-MAX TIM40J NLX nano S120 NE136 NL400BSET5PCB EL400JS120 Ti-Max NL400 T-Force DA-700 EL400S120 TI-MAX TIM40 NE278 nano400 NE161 ELM40M NLZ E U NLZ CDB NLZ E S120 NLZ NLZ Endo NLZ S120 NLZ U X85 nano95LS X25 X95 Z85L M25 M95L M15 X25L M95 X85L X15 X95L Z15L X12 Z25L X20L M15L M25L X15L nano25LS Z10L X12L ELEC-MATE Ti65 Ti-ENDO Ti65L SGMS-ER20i TEP-ER10 BB-EC FX65 N-30U EX-5B NM-E64R X65L EX-ENDO 128 NAC-EC NBBW-EC TEP-E10R EX-6D NBBW-E EX-6B NAC-E16R EX-5 FFB-EC E-TYPE CONTRA ANGLE NAC-E FPB-ECM MP-ER64 TEQ-E10R ARK-2 NM-EC EX-6 FPB-EC EX-6BM NM-E FX75 EX-6L FX23 X65 Ti65LA EX-8 ARS-1 NE134 VA750 120S VA750LUX120S VA750 120 VA750LUX230S Varios 75 VA750 230S PD-RA95 NSK Sterile Blades PD-DA-W PD-RA-H PD-2SES PD-2AL PD-DA-P PD-1A95 PD-DA-K PD-SA-S P200-REC P200-CRD-P P200-WPD PD-3GAS P200-RA330-L P200-SAG P200-RA135 P200-OSC-S-HS PD-2AM PD-CA-64 P200-HMH-HS PD-3GAL P200-CU-230 PD-CA-256 P200-2SL PD-2SD PD-3GAM P200-2AL P200-BMH-HS P200-CRA P200-RCRD-P NSK Sterile Burs/Disk P200-SMH P200-2SMS P200-CRD-M PD-CRA PD-2SL P200-1A175 P200-2SES P200-1A155-C PD-DA-J6 NSK Sterile Burs/Drills P200-CU-120 P200-2SM P200-REC-S P200-SMH-S P200-CA-4 P200-REC-S-HS PD-RA-A PD-1A75 PD-CA-16 P200-2SD P200-3GAM P200-HMH PD-1A175-10 P200-RCRD-L PD-RA330-L P200-RA155 PD-1A175 PD-RA-M PD-2SM P200-2AMS P200-3MC PD-DA-J4 PD-2SS PD-2AS P200-3GAS P200-SAG-S P200-OSC PD-RA155 PD-CRD-L PD-2SDM PD-RA-T PD-2AD PD-DA-A P200-RA330 PD-1A155 P200-OSC-S P200-1A175-C PD-CRD-P P200-PER P200-2AS P200-SMH-HS PD-PER P200-SAG-S-HS P200-2AM PD-1A135 PD-RA330 PD-1A155-10 P200-BMH PD-CRD-M PD-2AES P200-1A155 P200-2SS P200-1A135 P200-3GAL P200-RCRD-M P200-2AES P200-1A155-U PD-2ADM PD-RA135 P200-CRD-L NSK Sterile Rasps/Files PD-SA-R Primado2 Viva Mate 3U ViVa 3 S 120V Viva Mate 3 Viva Mate HANDY-MATE NSK PUSH-BUTTON MIDWEST REPLACEMENT Surgic IV Implant Control Unit Surgic XT Plus 230V OPT SurgicXTSTT120ERMS Surgic XT P12 SurgicXT Plus W/O(120V) Surgic XT Plus 120V LED Surgic XTS120 Surgic AP S 120 Surgic AP S 230 Surgic XT Plus 230V N-OPT SG50MS Motor Surgic AP(120V) Surgic XTSTT230ERMS SGL50M Motor Surgic XTSTT120MS w/o HP SG50LED Surgic XTSTT120ERMS Surgic XT Plus 120V N-OPT SurgicXTSTT120MS without Handpiece Surgic XT12 w/o HP SGL50M Surgic XT P23 SG50M SG50MS NE179 Surgic XT Plus 120V OPT FX58m FX20m FX55m FX25 FX57K FX20K FX25K FX22 FX15 FX57 IS-205 M4 EX-203 M4 PTL-950Ti EX-203C B2 FX205 B2 EX-203 B2 FX204 M4 Ti205L EX-204 M4 EX-203C M4 EX-103 M4 PTL-CR iProphy Air PTL-CD PTL-950 PTL-SDN(W/O FIBER) EX-117 AIR MOTOR HANDPIECE TN-102 FX205 M4 IS-205 B2/3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2008-03-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-03-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-07-11
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	2008-06-09
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2013-05-16
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2022-10-19
EWQ	Saw, Surgical, Ent (Electric Or Pneumatic)	Ear, Nose, Throat	Class 1	874.4420	2008-06-09
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2013-11-29
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2018-07-20
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2018-07-20
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2018-07-20
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2022-01-24
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-09-18
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2009-04-30
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2009-05-04
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-09-22
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-04-17
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2012-02-14
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2007-05-18
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2008-04-07
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-03-18
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2024-07-01
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-08-30
DWI	Saw, Electrically Powered	General, Plastic Surgery	Class 1	878.4820	2008-06-09
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2013-11-29
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2020-12-07
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2013-11-29
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2018-08-30
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-12-25
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2025-12-25
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2024-05-01
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2008-03-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2024-09-24
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2024-07-01
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-03-18
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2008-03-18
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2008-03-27
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2018-01-10
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2018-01-10
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2013-11-29
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2015-02-04
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2017-09-25
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2017-09-25
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2019-05-30
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2008-03-18
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2008-03-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-05-16
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-12-30
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-12-30
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-12-30
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2013-12-30
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2009-12-04
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-03-18
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2008-03-18
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-03-02
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-03-18

Official Correspondent

JungHee Kim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NAKANISHI INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611253	NAKANISHI INC.	Kanuma Tochigi, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number	Establishment Name	Location
3014683120	JMU DENTAL, INC	Fullerton, CA, US
3011300255	W&H DENTALWERK BUERMOOS GMBH - SITE 2	BUERMOOS Salzburg, AT
9681479	W&H DENTALWERK BUERMOOS GMBH	BUERMOOS Salzburg, AT
9611253	NAKANISHI INC.	Kanuma Tochigi, JP
3009161350	PALTOP ADVANCED DENTAL SOLUTIONS LTD	Caesarea Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1422375. Last updated year: 2026. Please use registration number 1422375 when referencing this establishment in official correspondence.