FDA Registration Active 🇺🇸 United States

NSK AMERICA CORP.

Reg #: 1422375 · FEI: 1000139790 · Expires 2026
Products
21
Proprietary Names
951
Establishment Types
2
Classifications
21

Registration Details

Registration Name
NSK AMERICA CORP.
Registration Number
1422375
FEI Number
1000139790
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1800 Global Parkway
City
Hoffman Est
State
IL
ZIP
60192
Country
US

Regulatory Submissions

510(k) Number
K970953

Owner / Operator

Firm Name
NAKANISHI INC.
Operator Number
8030216
Address
700 Shimohinata
City
Kanuma
State
Tochigi
Postal Code
322-8666
Country
JP
Correspondent
JungHee Kim

Products

Device Name Product Code
Handpiece, Rotary Bone Cutting KMW
Scaler, Ultrasonic ELC
Handpiece, Air-Powered, Dental EFB
Saw, Powered, And Accessories HAB
Saw, Surgical, Ent (Electric Or Pneumatic) EWQ
Handpiece, Direct Drive, Ac-Powered EKX
Handpiece, Contra- And Right-Angle Attachment, Dental EGS
Controller, Foot, Handpiece And Cord EBW
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
Motor, Drill, Electric HBC
Bur, Surgical, General & Plastic Surgery GFF
Motor, Surgical Instrument, Ac-Powered GEY
Accessories, Implant, Dental, Endosseous NDP
Saw, Electrically Powered DWI
Drill, Bone, Powered DZI
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Locator, Root Apex LQY
Agent, Polishing, Abrasive, Oral Cavity EJR
Airbrush KOJ
Blade, Saw, General & Plastic Surgery, Surgical GFA

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 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 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 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 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 TEP-ER10 BB-EC N-30U NM-E64R 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 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 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 iPex E set NE181 IPEX FLASH pearl Perio Mate Powder S-Max M500K MC-E TU B2/3 PAE-SU M N-75S AK400L Ti-Max A500L Ti-Max A700 N-75T MLXT-MU PAE-S M4 PAP-MU M4 S-Max M600KL N-75M Ti-Max AK600L S-Max M500BL S-Max M600K ML-XT TU PE-MS NL-75M MC-QD SU CH45-QD PAE-TU B2 ML-XT MU M600LG M4 S-Max M500L M500LG B2 AK455L TU AT450 B2 N-45S M600LG B2 S-Max pico MWL Ti-Max A500 PTL-MS MC-E SU B2/ PAP-SU B2 S-Max M500WL Ti-Max A600L Ti-Max AK700L S-Max M600 PAP-SU 5H PAE-TU M4 PANA AIR E M PAP-SU M4 PANA-MAX SU M4 MC-QD TU AS455L TU PAP-MU B2 MC2-MU ALPHA AIR HANDPIECE, ULTRA-PUSH, AL S-Max M600L Ti-MaxNL-95W T(BRA) S-Max M500 AW450L SU NL-75T Ti-Max A700L AW300L S-Max M600BL PA2000 SU M4 Ti-MaxNL-95W M(BRA) PAE-T B2 A450L MC2-SU S-Max M500SL AS450L SU PANA-MAX TU B2 S-Max M500KL S-Max M600WL Ti-Max A600 S-Max M600BLED AT450 M4 AK450L SU S-Max pico STL PHATELUS 45 SU S-Max M600WLED PANA-MAX SU B2 PANA-MAX TU M4 AB450L SU MLXT-TU S-Max M600SL PAE-M M4 S-Max pico WHL PAE-M B2 MLXT-SU AW455L TU MC2-EMU B2 PAE-SU B2 PHATELUS 45 TU PAE-S B2 PAP-MU 5H PAE-T M4 N-45T PAE-MU B2 V-G76 G12 V10 P1 V-P26R P26L P25R G1 G62D P40 V-G77 P21R VARIOS G9 G2-E V10-E VA970 120V V-G87 E4 G67D P1D G22 P20 V-G72 P3D G21 G4 G7 P21L V-S51D E30LD G5 G16 U files 33mm ISO 30 VA2-LUX-SC Ti VA970 LUX 120V V-S53 U files 33mm ISO 35 P26R V-S50 V-S52D G68D E31D G28 VA170-SC P25R-E Tip Cap E7 P21R-E G65D G66D E5 V-S3 V-G71 U files 33mm ISO 15 E8 P25L-E V-G79 VA170LUX-SC G2 E12 E32D V-N50 Varios 970 Unit NA V-S53D V-S50D U files 33mm ISO 20 E9D G61D G13 V-G70 P11L E14D V-P11L V-P12 G26 G11 E15D P41 V-P10 V-S1 Varios 970 V-G78 G3-E V-P26L G3 V-P11R G8 E7D G1-E V-G75 G6-E P11R E30RD V30 G25 P20-E E4D P2D G6 V-G82 V-S51 V-N51 U files 33mm ISO 25 V-S52 G4-E E8D P25L E11 P10 E9 V-S33 P21L-E E6 iCare Care3 Plus C0TYPE 120V Care3 Plus C3TYPE 120V Care3 Plus C1TYPE 120V Care3 Plus C1TYPE 230V Care3 Plus C2TYPE 120V Care3 Plus UBS-RCD130C2-40 UBS-RD130C3-45 UBS-RD130C3-30 UBS-RD50C2-15 UBS-RD130C3-40 UBS-RD70C1-30 UBS-RD70C2-06 UBS-RCD130C2-30 UBS-RD70C1-20 UBS-RD70C2-15 UBS-RD70C2-07 UBS-RD50C2-07 UBS-RD70C2-10 UBS-RCD130C3-40 UBS-RD130C2-45 UBS-RCD130C2-45 UBS-RD50C2-10 UBS-RD50C1-20 UBS-RCD130C3-30 UBS-RD50C2-06 UBS-RD50C1-30 UBS-RD130C2-40 UBS-RD70C2-08 UBS-RD50C2-08 UBS-RD130C2-30 UBS-RCD130C3-45 P300-1T130-PB P300-2A80 P300-1T170 P300-2S10 P300-2S80 P300-2S20 P300-2A100 P300-1T110-C P300-2S60 P300-1T110 P300-2A40 P300-2A60 P300-2S100 P300-2A20 P300-2S120 P300-1AHA P300-2S40 P300-2A120 P300-2A10 P300-1T110-PB P300-1T240 P300-1T130 P300-1AHS P300-1T130-C Prophy Kit2 FC-83 Powder Handpiece(For Prophy use) Powder Handpiece(For Perio use) Varios Combi Pro2 Basic Set Perio Kit2 SG14L SG15C SG11 SG12 SG5 SG1 SG8A SG2R H-SG8 M-RE2 SCL4D SG2L SG9 VSRG120V1 VA-SGN-HPSC E30LD-S H-SG8R SG4 VarioSurg VSRG OPT (120V) SG19 SG10 SCL1D SG16A SG1A SCL5 VS-LED-HPSC P25R-S SG6D SCL1 SG15A SG7D VSRG230V1 NE214 SG18L H-SG8L M-ST1 SCL3D V10-S E32D-S SCL5D SCL2D E31D-S VSRG120V2 H-SG1 SG68 P25L-S M-OC1L SG16B SG15D SG14R SG18R SG30 SG3 SCL3 M-OC1R E30RD-S G1-S VarioSurg-HPSC SG58 SG17 SG15B P20-S SG8 Ti-Max X450MWL Ti-Max X450L Ti-Max X450WLED Ti-Max X450 5H Ti-Max X450 Ti-Max X450WHL Ti-Max X450KL Ti-Max X450STL Ti-Max X450 M4 Primado Blade

Establishment Types

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