Nakanishi Inc.

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
40
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0222-2019Class IISurgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical HandpJune 1, 2018
Z-0221-2019Class IISurgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical HandpieJune 1, 2018
Z-0225-2019Class IIMicro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. June 1, 2018
Z-0223-2019Class IIMicro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. ThJune 1, 2018
Z-0219-2019Class IISurgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical HandpiecJune 1, 2018
Z-0226-2019Class IIMicro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. TJune 1, 2018
Z-0220-2019Class IISurgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical HandpieJune 1, 2018
Z-0224-2019Class IIMicro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc ThJune 1, 2018
Z-2674-2016Class IIDiamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The iJuly 8, 2016
Z-2672-2016Class IIDiamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VJuly 8, 2016
Z-2673-2016Class IIDiamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and withoJuly 8, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K260773Varios Combi Pro2March 10, 2026
K254163VarioSurg 4December 23, 2025
K252662UniBurSeptember 19, 2025
K251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SSeptember 19, 2025
K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate NozzSeptember 20, 2024
K233288NLZ Built-In Motor SystemJune 24, 2024
K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)June 20, 2024
K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)April 25, 2024
K230888Titanium TurbineJune 2, 2023
K230106General Cutting StraightMay 24, 2023
K222518FX ContraNovember 17, 2022
K203791Stainless TurbineJune 21, 2022
K202120P300 AttachmentOctober 22, 2021
K211584Oral Surgery ContraAugust 19, 2021
K202960General Cutting Contra HandpieceOctober 27, 2020
K182999General Cutting Contra HandpieceApril 16, 2019
K173905Surgic Pro, Surgic Pro+June 19, 2018
K171155Surgical Angle Handpiece, Surgical Straight HandpieceNovember 21, 2017
K163402NLZ Motor SystemAugust 31, 2017
K163483PANA SPRAY PlusAugust 15, 2017