Nakanishi Inc.
FDA Regulatory Profile
Nakanishi Inc. appears in FDA public data with 11 recalls, 40 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0223-2019, Class II) was initiated on June 1, 2018. Its most recent 510(k) clearance was granted on March 10, 2026.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 40
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0223-2019 | Class II | Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. Th | June 1, 2018 |
| Z-0224-2019 | Class II | Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc Th | June 1, 2018 |
| Z-0225-2019 | Class II | Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. | June 1, 2018 |
| Z-0219-2019 | Class II | Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpiec | June 1, 2018 |
| Z-0222-2019 | Class II | Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handp | June 1, 2018 |
| Z-0226-2019 | Class II | Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. T | June 1, 2018 |
| Z-0220-2019 | Class II | Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpie | June 1, 2018 |
| Z-0221-2019 | Class II | Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpie | June 1, 2018 |
| Z-2674-2016 | Class II | Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The i | July 8, 2016 |
| Z-2673-2016 | Class II | Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and witho | July 8, 2016 |
| Z-2672-2016 | Class II | Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, V | July 8, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260773 | Varios Combi Pro2 | March 10, 2026 |
| K254163 | VarioSurg 4 | December 23, 2025 |
| K252662 | UniBur | September 19, 2025 |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 S | September 19, 2025 |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozz | September 20, 2024 |
| K233288 | NLZ Built-In Motor System | June 24, 2024 |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | June 20, 2024 |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | April 25, 2024 |
| K230888 | Titanium Turbine | June 2, 2023 |
| K230106 | General Cutting Straight | May 24, 2023 |
| K222518 | FX Contra | November 17, 2022 |
| K203791 | Stainless Turbine | June 21, 2022 |
| K202120 | P300 Attachment | October 22, 2021 |
| K211584 | Oral Surgery Contra | August 19, 2021 |
| K202960 | General Cutting Contra Handpiece | October 27, 2020 |
| K182999 | General Cutting Contra Handpiece | April 16, 2019 |
| K173905 | Surgic Pro, Surgic Pro+ | June 19, 2018 |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | November 21, 2017 |
| K163402 | NLZ Motor System | August 31, 2017 |
| K163483 | PANA SPRAY Plus | August 15, 2017 |