FDA Registration
Active
🇯🇵 Japan
NAKANISHI INC.
Reg #: 9611253
·
FEI: 3002807687
·
Expires 2026
Products
23
Proprietary Names
951
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- NAKANISHI INC.
- Registration Number
- 9611253
- FEI Number
- 3002807687
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 700 SHIMOHINATA
- City
- Kanuma Tochigi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K991021
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
US Agent
- Business Name
- NSK AMERICA CORPORATION
- Contact Name
- SEAN KAUFMAN
- Address
- 1800 Global Pkwy
- City
- Hoffman Est
- State
- IL
- ZIP
- 60192
- Country
- US
- [email protected]
- Phone
- 888 6751675
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2008-03-18 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2022-10-19 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2008-03-18 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2008-03-18 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2007-05-18 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2008-03-18 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2018-02-05 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2008-07-10 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2009-05-04 |
| Handpiece, Rotary Bone Cutting | KMW | Class 2 | Dental | No | 2018-07-20 |
| Airbrush | KOJ | Class 2 | Dental | No | 2026-03-12 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2014-11-20 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2025-09-21 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2008-06-09 |
| Saw, Electrically Powered | DWI | Class 1 | General, Plastic Surgery | No | 2008-06-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2008-04-07 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2019-06-13 |
| Saw, Surgical, Ent (Electric Or Pneumatic) | EWQ | Class 1 | Ear, Nose, Throat | No | 2008-06-09 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2006-05-25 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2013-12-30 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2009-05-04 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2024-09-24 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2007-05-18 |
Proprietary Names
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
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
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
ELEC-MATE
NE134
VA750 120S
VA750LUX120S
VA750 120
VA750LUX230S
Varios 75
VA750 230S
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
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
NE171
VA560LUX230S
VA560 230S
VA560 120S
ULTRASONIC SCALER
VARIOS 560
VA560LUX120S
Surgic XT
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
X85
nano95LS
X25
X95
Z85L
M25
M95L
M15
X25L
M95
X85L
X15
X95L
Z15L
X12
Z25L
X20L
M15L
M25L
X15L
nano25LS
Z10L
X12L
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
NSK PUSH-BUTTON MIDWEST REPLACEMENT
iSD-HP
EM10M3
iSD120V1
Primado Bur
PANA SPRAY Plus
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
SGS-E
SGS-ES
SGA-ES
SGA-E2S
SGS-E2G
SGS-E2S
SGA-E2G
SGA-E
Ti-Max Z45
Z45L
iCare
Care3 Plus C0TYPE 120V
Care3 Plus C3TYPE 120V
Care3 Plus C1TYPE 120V
Care3 Plus C1TYPE 230V
Care3 Plus C2TYPE 120V
Care3 Plus
Prophy Kit2
FC-83
Powder Handpiece(For Prophy use)
Powder Handpiece(For Perio use)
Varios Combi Pro2 Basic Set
Perio Kit2
EX-5B
FX65K
FX50m
X65
X65L
FX65
FX50K
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
Ti65
Ti-ENDO
Ti65L
SGMS-ER20i
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
X-SG25L
X-SG93
X-SG93L
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
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
M205
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
VA170S11
VA170LUXS10
VA170LUXS11
VarioSurg 4 (120V)
FC-86
VarioSurg 4 w/o FC (120V)
VS4-LED-HPSC
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
VA370NA
VA370ADNA
Forza V3
VA370LUXADNA
VA370
SY-LUX-HP
VA370LUXNA
Forza V3 LED
VA370 Lux
Varios 370
Primado
FX58m
FX20m
FX55m
FX25
FX57K
FX20K
FX25K
FX22
FX15
FX57
PER-PTL-P
Perio Mate Nozzle Tip
PER-KV-P
PER-M4-P
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
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
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
iPex E set
NE181
IPEX
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
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
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
Viva Mate 3U
ViVa 3 S 120V
Viva Mate 3
Viva Mate
HANDY-MATE
Multi Pad2
NLZ BF SET
NLZ SEL SET
Multi Pad 2 SET
NLZ SELB SET
NLZ PRO
NLZ BFB SET
Primado Surgical System
SGL80M
Surgic Pro2 OPT
Surgic Pro2 NON-OPT
FC-81
SG80M
NLZ E U
NLZ CDB
NLZ E S120
NLZ
NLZ Endo
NLZ S120
NLZ U
iProphy mobile Motor
iProphy mobile complete set
VA150
VA350S230V
Varios
VA350LUX120
NE149
VA350S120V
DA150SL
Varios 350
VA150LUX
VA150LUX BEL - NA
Primado Blade
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
FLASH pearl
Perio Mate Powder
PRIMADO SURGICAL SYSTEM
Z890L
Z990KL
Z990WL
Z micro KL
Z890WL
Z890KL
Z micro
Z990L
Z95L
Z99L
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)