Manufacturer

Nakanishi

JapanLegal entities : Nakanishi Inc.

Markets : Germany · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 40 · class I, II · latest in 2026 · see on the FDA website

EU representative : NSK Europe GmbH (Germany)

Website

17 categories, 457 models including 456 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Dental drills	Z12110102	BA175E93/42 BA25E93/42 BA280L93/42 BA45E93/42 BA520FB93/42 127 others BA520FM93/42 BA602ES93/42 BA604E93/42 BA604ES93/42 BA66E93/42 BB-Y C03793/42 E200IL93/42 E205IL93/42 EC-30M93/42 ER1693/42 ER20i93/42 ER493/42 ER4M93/42 ER6493/42 FFB-Y93/42 FPB-Y93/42 FX205 M493/42 FX205m B293/42 FXP-MU B293/42 FXP-MU M493/42 FXP-SU B293/42 FXP-SU M493/42 FXP-SU QD93/42 H311L93/42 iSD-HP93/42 M micro PA230693/42 M micro SL93/42 M500LG M493/42 M500LG QD93/42 M600LG M493/42 M600LG QD93/42 M80093/42 M800BL93/42 M800KL93/42 M800SL93/42 M800WL93/42 M90093/42 M900BL93/42 M900K93/42 M900KL2 refs93/42 M900L2 refs93/42 M900W93/42 M900WL93/42 MDA00000273 refs MDA0000032 MDA00000333 refs MDA00000353 refs MDA0000040 MDA00000602 refs MDA00000843 refs MP-ER6493/42 MP-F10R93/42 MP-F16R93/42 MP-F20R93/42 MP-Y93/42 MPA-F16R93/42 MPAS-F16R93/42 MPAS-F20R93/42 MPAS-Y93/42 NAC-EC93/42 NAC-Y93/42 NLZ Endo93/42 PAF-S B293/42 PAF-S M493/42 PAF-SU M493/42 PAF-SU QD93/42 Pana-Max2 B293/42 Pana-Max2 KV93/42 Pana-Max2 M493/42 Pana-Max2 QD93/42 Pana-Max2R B293/42 PAP-MU M493/42 PAP-QD MU93/42 PAP-SU M493/42 S-Max pico93/42 S-Max pico B293/42 S-Max pico KL93/42 S-Max pico M493/42 S-Max pico QD93/42 SG2093/42 SG20M93/42 SGA-ES93/42 SGM-ER20i93/42 SGM-I93/42 SGMS-I93/42 SGO-493/42 SGO-593/42 SGO2-E93/42 SGR-193/42 SGR-293/42 SGR-393/42 SGR2-E93/42 SGS-E2S93/42 SGS-ES93/42 SGT-293/42 SGT2-E93/42 TEP-ER1093/42 TEP-Y93/42 TEQ-Y93/42 Ti-ENDO93/42 VM-Y93/42 X-DSG2093/42 X-DSG20h93/42 X-DSG20L93/42 X-SG20L93/42 X-SG20ML93/42 X-SG25L93/42 X-SG6593/42 X-SG65L93/42 X-SG9393/42 X-SG93L93/42 X450KL93/42 X450M493/42 X450QD93/42 X450SL93/42 Z micro PA235793/42 Z micro SL93/42 Z-SG4593/42 Z800KL93/42 Z800L93/42 Z800SL93/42 Z800WL2 refs93/42 Z900KL93/42 Z900L93/42 Z900SL93/42 Z900WL2 refs93/42 M600L93/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Instruments for dental treatment units - other	Z12110199	E1193/42 E1293/42 E15D93/42 E30LD93/42 E30LD-S93/42 93 others E30RD93/42 E30RD-S93/42 E31D93/42 E31D-S93/42 E32D93/42 E32D-S93/42 E493/42 E4D93/42 E593/42 E693/42 E793/42 E7D93/42 E893/42 E8D93/42 FX205 B293/42 FX205 M493/42 G1-S93/42 G61D93/42 G62D93/42 G65D93/42 G66D93/42 G67D93/42 G68D93/42 H-SG193/42 H-SG893/42 H-SG8L93/42 H-SG8R93/42 MDA00000873 refs MDA0000142 P20-S93/42 P25L-S93/42 P25R-S93/42 SCL193/42 SCL1D93/42 SCL2D93/42 SCL393/42 SCL3D93/42 SCL4D93/42 SCL593/42 SCL5D93/42 SG193/42 SG1093/42 SG1193/42 SG14L93/42 SG14R93/42 SG15A93/42 SG15B93/42 SG15C93/42 SG15D93/42 SG16A93/42 SG16B93/42 SG1793/42 SG18L93/42 SG18R93/42 SG1993/42 SG1A93/42 SG2L93/42 SG2R93/42 SG393/42 SG3093/42 SG493/42 SG593/42 SG5893/42 SG6893/42 SG6D93/42 SG7D93/42 SG893/42 SG8A93/42 SG993/42 U files 33mm ISO 1593/42 U files 33mm ISO 2093/42 U files 33mm ISO 2593/42 U files 33mm ISO 3093/42 U files 33mm ISO 3593/42 V-G7093/42 V-G7193/42 V-G7293/42 V-G7593/42 V-G7693/42 V-G7793/42 V-G7893/42 V-G7993/42 V-S5093/42 V-S5193/42 V-S51D93/42 V-S5293/42 V-S52D93/42 V-S5393/42 V-S53D93/42 V1093/42 V10-S93/42 V3093/42 X205L93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	MDA0000008 P200-1A13593/42 P200-1A15593/42 P200-1A155-C93/42 P200-1A17593/42 56 others P200-1A175-C93/42 P200-2AES93/42 P200-2AL93/42 P200-2AM93/42 P200-2AMS93/42 P200-2AS93/42 P200-2SD93/42 P200-2SES93/42 P200-2SL93/42 P200-2SM93/42 P200-2SMS93/42 P200-2SS93/42 P200-3GAL93/42 P200-3GAM93/42 P200-3GAS93/42 P200-3MC93/42 P200-BMH93/42 P200-BMH-HS93/42 P200-CU-23093/42 P200-HMH93/42 P200-HMH-HS93/42 P200-OSC93/42 P200-OSC-S93/42 P200-OSC-S-HS93/42 P200-RA33093/42 P200-RA330-L93/42 P200-REC93/42 P200-REC-S93/42 P200-REC-S-HS93/42 P200-SAG93/42 P200-SAG-S93/42 P200-SAG-S-HS93/42 P200-SMH93/42 P200-SMH-HS93/42 P200-SMH-S93/42 P200-WPD93/42 P300-1AHA93/42 P300-1AHS93/42 P300-1T11093/42 P300-1T110-C93/42 P300-1T110-PB93/42 P300-1T13093/42 P300-1T130-C93/42 P300-1T130-PB93/42 P300-1T17093/42 P300-1T24093/42 P300-2A1093/42 P300-2A2093/42 P300-2A4093/42 P300-2A6093/42 P300-2A8093/42 P300-2S1093/42 P300-2S2093/42 P300-2S4093/42 P300-2S6093/42 P300-2S8093/42	IIa MDR, 93/42	EUDAMED record Report an error
Tartar ablators	Z12119001	G12 refs93/42 G1-E93/42 G1193/42 G1293/42 G1393/42 43 others G1693/42 G293/42 G2-E93/42 G393/42 G3-E93/42 G42 refs93/42 G4-E93/42 G593/42 G62 refs93/42 G6-E93/42 G82 refs93/42 G92 refs93/42 MDA00002192 refs MDA00002202 refs P193/42 P1093/42 P11L93/42 P11R93/42 P1D93/42 P2093/42 P20-E93/42 P21L93/42 P21L-E93/42 P21R93/42 P21R-E93/42 P25L93/42 P25L-E93/42 P25R93/42 P25R-E93/42 P26L93/42 P26R93/42 P2D93/42 P3D93/42 P4093/42 P4193/42 Scalling G1 Pack93/42 Scalling G16 Pack93/42 Scalling G4 Pack93/42 Scalling G6 Pack93/42 Scalling G8 Pack93/42 Scalling G9 Pack93/42 VA370 Lux Unit93/42 Varios 170 Built-in Module93/42	IIa MDR, 93/42	EUDAMED record Report an error
Various dental stomatology instruments - hardware accessories	Z12119080	G9593/42 MDA00000292 refs MDA00000303 refs MDA00001242 refs MDA00001263 refs 34 others MDA0000128 MDA0000129 MDA0000136 MDA0000218 MDA0000223 MDA00002293 refs MDA0000280 Perio-Control Tips Air Scaler Kit93/42 S193/42 S1093/42 S293/42 S2093/42 S21L93/42 S21R93/42 S393/42 S3593/42 S65D93/42 S66D93/42 S67D93/42 S68D93/42 S71D93/42 S72D93/42 S7593/42 S81D93/42 S82D93/42 S83D93/42 S86D93/42 SPP00000013 refs V-U1593/42 V-U2093/42 V-U2593/42 V-U3093/42 V-U3593/42 Varios 170 H2393/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Instruments for dental treatment units - hardware accessories	Z12110180	MDA00000053 refs MDA00000283 refs MDA00000642 refs MDA0000069 MDA0000072 23 others MDA00000743 refs MDA0000076 MDA00001063 refs MDA00001083 refs MDA00001093 refs MDA00001213 refs MDA00001222 refs MDA0000123 MDA0000125 MDA00001273 refs MDA00001303 refs MDA0000131 MDA00001322 refs MDA0000138 MDA00002223 refs MDA00002252 refs MDA0000238 MDA0000251 MDA0000268 MDA00002822 refs MDA00002833 refs SPP00000003 refs VS3-LED-HPSC93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Dental prophylaxis equipment	Z12119007	AR-ER10(S)93/42 AR-Y(K)93/42 AR-Y(S)93/42 EVA-Y93/42 iFX5793/42 15 others MDA00000343 refs MDA00000513 refs MDA0000083 MDA0000227 MDA0000228 PR-F93/42 SGO-KV93/42 SGO-SR93/42 SPP00000043 refs V-P1093/42 V-P11L93/42 V-P11R93/42 V-P1293/42 V-P26L93/42 V-P26R93/42	IIa MDR, 93/42	EUDAMED record Report an error
Orthopaedic surgical drills	Z12130503	PD-DA-A93/42 PD-DA-J493/42 PD-DA-J693/42 PD-DA-K93/42 PD-DA-P93/42 5 others PD-DA-W93/42 PD-RA-A93/42 PD-RA-H93/42 PD-RA-M93/42 PD-RA-T93/42	IIa 93/42	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - hardware accessories	Z12019080	MDA00000012 refs MDA00001103 refs MDA00001113 refs MDA00001123 refs MDA00001132 refs 5 others MDA00001142 refs MDA0000115 MDA0000116 MDA0000120 MDA0000137	I MDR	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - hardware accessories	Z12130580	MDA0000117 MDA0000118 MDA0000119	I MDR	EUDAMED record Report an error
Orthopaedic surgical saws	Z12130502	PD-SA-R93/42 PD-SA-S93/42	IIa 93/42	EUDAMED record Report an error
Apex locators	Z12119009	MDA0000067	I MDR	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - hardware accessories	Z12011380	MDA00001503 refs	I MDR	EUDAMED record Report an error
Cold light dental equipment	Z12119003	MDA0000144	I MDR	EUDAMED record Report an error
Drills for neurosurgery	Z12100902	P200-PER93/42	IIa 93/42	EUDAMED record Report an error
Instruments for motorised neurosurgery systems - hardware accessories	Z12100980	P200-CRA93/42	IIa 93/42	EUDAMED record Report an error
Various orthopaedic and traumatology instruments - hardware accessories	Z12139080	MDA00000622 refs	I MDR	EUDAMED record Report an error

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