# Nakanishi, Inc.

- Location (FDA's records): Kanuma, JP
- FDA decisions: 40 (2001–2026): 40 510(k) clearances
- Product codes: EFB (10), ELC (7), EBW (7), EGS (5), DZI (2), HBE (2), KMW (2), HBC (2), EKX (2), ERL (1)
- 510(k) review time since 2016: median 209 days, against 227 for FDA's reviews in the same codes and years (7 of 13 faster)
- Predicates its devices cite: 48 (14 its own); citations of its devices by later devices: 34 (14 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W&H Dentalwerk Buermoos GmbH: 4 (https://510kreport.com/company/w-h-dentalwerk-buermoos)
- W&H Dentalwerk Bürmoos GmbH: 3 (https://510kreport.com/company/w-h-dentalwerk-burmoos)
- E.M.S Electro Medical Systems S.A: 3 (https://510kreport.com/company/ems-electro-medical-systems-s-a)
- Scican, Ltd.: 3 (https://510kreport.com/company/scican)
- Dentsply Sirona: 2 (https://510kreport.com/company/dentsply-sirona)
- A-Dec, Inc.: 2 (https://510kreport.com/company/a-dec)
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Stryker Instruments: 2 (https://510kreport.com/company/stryker-instruments)

## Firms that cite its devices most
- Micro-Nx Co., Ltd.: 2 (https://510kreport.com/company/micro-nx)
- Dentalez Group, Stardental Division: 2 (https://510kreport.com/company/dentalez-group-stardental-division)
- Guangdong Jinme Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/guangdong-jinme-medical-technology)
- Mgnewton, Ltd.: 1 (https://510kreport.com/company/mgnewton)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- Foshan Cicada Dental Instrument Co, Ltd.: 1 (https://510kreport.com/company/foshan-cicada-dental-instrument)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)
- Kavo DO Brasil Industria E Comercio Ltda: 1 (https://510kreport.com/company/kavo-do-brasil-industria-e-comercio)

## Its most-cited devices
- K173905: Surgic Pro, Surgic Pro+ (2018), cited by 4
- K163131: A-dec NLZ Electric Motor System (2017), cited by 4
- K031421: Ultrasonic Scaler, Models Varios 350 Lux, Varios 350 (NO Light), Varios 550, Varios 150 Lux, Varios 150 (NO Light) (2004), cited by 3
- K132264: PRIMADO2 Total Surgical System (2013), cited by 3
- K112024: TI-Max X450 (2012), cited by 3
- K032395: Prophy-Mate (2003), cited by 2

## Recent decisions
- K260773: Varios Combi Pro2 (Mar 10, 2026)
- K254163: VarioSurg 4 (Dec 23, 2025)
- K252662: UniBur (Sep 19, 2025)
- K251689: Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11) (Sep 19, 2025)
- K241880: Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (Sep 20, 2024)
- K233288: NLZ Built-In Motor System (Jun 24, 2024)
- K233117: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (Jun 20, 2024)
- K233308: Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (Apr 25, 2024)

Source page: https://510kreport.com/company/nakanishi