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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Rotary Bone Cutting | KMW | Class 2 | Dental | No | 2008-03-18 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2008-03-18 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2023-07-11 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2008-06-09 |
| Saw, Surgical, Ent (Electric Or Pneumatic) | EWQ | Class 1 | Ear, Nose, Throat | No | 2008-06-09 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2013-11-29 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2018-07-20 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2018-07-20 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2008-09-18 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2009-04-30 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2009-05-04 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2007-05-18 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2008-04-07 |
| Saw, Electrically Powered | DWI | Class 1 | General, Plastic Surgery | No | 2008-06-09 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2025-12-25 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-12-30 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2013-12-30 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2006-05-25 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2024-09-24 |
| Airbrush | KOJ | Class 2 | Dental | No | 2026-03-12 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2009-05-04 |
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