Medical Device Manufacturer · JP , Kanuma

Nakanishi, Inc.

40 submissions · 40 cleared · Since 2001
40
Total
40
Cleared
0
Denied

Nakanishi, Inc. — FDA 510(k) Submissions

Nakanishi, Inc. has submitted 40 FDA 510(k) premarket notifications since 2001, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Handpiece, Air-powered, Dental, Scaler, Ultrasonic, Controller, Foot, Handpiece And Cord, Handpiece, Contra- And Right-angle Attachment, Dental, Drill, Bone, Powered . Use the specialty filter in the sidebar to narrow results.

40 devices
1–25 of 40
Varios Combi Pro2
K260773 · ELC Scaler, Ultrasonic · Dental
Mar 2026 1d
VarioSurg 4
K254163 · DZI Drill, Bone, Powered · Dental
Dec 2025 1d
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
K251689 · ELC Scaler, Ultrasonic · Dental
Sep 2025 109d
UniBur
K252662 · HBE Drills, Burrs, Trephines... · Neurology
Sep 2025 28d
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
K241880 · EFB Handpiece, Air-powered,... · Dental
Sep 2024 84d
NLZ Built-In Motor System
K233288 · EBW Controller, Foot,... · Dental
Jun 2024 269d
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
K233117 · EBW Controller, Foot,... · Dental
Jun 2024 267d
Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
K233308 · EFB Handpiece, Air-powered,... · Dental
Apr 2024 209d
Titanium Turbine
K230888 · EFB Handpiece, Air-powered,... · Dental
Jun 2023 63d
General Cutting Straight
K230106 · EGS Handpiece, Contra- And... · Dental
May 2023 131d
FX Contra
K222518 · EGS Handpiece, Contra- And... · Dental
Nov 2022 90d
Stainless Turbine
K203791 · EFB Handpiece, Air-powered,... · Dental
Jun 2022 540d
P300 Attachment
K202120 · HBE Drills, Burrs, Trephines... · Neurology
Oct 2021 449d
Oral Surgery Contra
K211584 · KMW Handpiece, Rotary Bone... · Dental
Aug 2021 87d
General Cutting Contra Handpiece
K202960 · EGS Handpiece, Contra- And... · Dental
Oct 2020 27d
General Cutting Contra Handpiece
K182999 · EGS Handpiece, Contra- And... · Dental
Apr 2019 168d
Surgic Pro, Surgic Pro+
K173905 · EBW Controller, Foot,... · Dental
Jun 2018 179d
Surgical Angle Handpiece, Surgical Straight Handpiece
K171155 · KMW Handpiece, Rotary Bone... · Dental
Nov 2017 215d
NLZ Motor System
K163402 · EBW Controller, Foot,... · Dental
Aug 2017 269d
PANA SPRAY Plus
K163483 · EFB Handpiece, Air-powered,... · Dental
Aug 2017 246d
A-dec NLZ Electric Motor System
K163131 · EBW Controller, Foot,... · Dental
May 2017 184d
PRIMADO2 TOTAL SURGICAL SYSTEM
K132264 · HBC Motor, Drill, Electric · Neurology
Dec 2013 148d
IPROPHY MOBILE
K131578 · EKX Handpiece, Direct Drive,... · Dental
Sep 2013 104d
ULTRASONIC SCALER
K113717 · ELC Scaler, Ultrasonic · Dental
Mar 2013 442d
TI-MAX Z45
K121901 · EGS Handpiece, Contra- And... · Dental
Feb 2013 244d
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