510(k) Report

FDA applicant

Nakanishi, Inc.

Kanuma, JP40 decisions2001–202610 recalls

FDA records 40 decisions for Nakanishi, Inc. (Kanuma, JP) from 2001 to 2026: 40 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and ELC (Scaler, Ultrasonic). Since 2016 its 510(k)s took a median of 209 days from receipt to decision, against 227 for FDA’s reviews in the same codes and years. Its devices cite 48 predicates, 14 of them its own earlier devices. 10 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Nakanishi, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2007: 12008: 32009: 22012: 42013: 52017: 42018: 12019: 12020: 12021: 22022: 22023: 22024: 42025: 32026 (partial year): 1
2007high 5 (2013) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

8in 2018

2016: 22018: 8
2007high 8 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nakanishi, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nakanishi, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EFBHandpiece, Air-Powered, Dental10decisions
  • ELCScaler, Ultrasonic7decisions
  • EBWController, Foot, Handpiece And Cord7decisions
  • EGSHandpiece, Contra- And Right-Angle Attachment, Dental5decisions
  • DZIDrill, Bone, Powered2decisions
  • HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)2decisions

Also: KMW (2), HBC (2), EKX (2), ERL (1).

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 209 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 227 days; 7 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 48 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173905Surgic Pro, Surgic Pro+Nakanishi, Inc. · 20184cite it
  • K163131A-dec NLZ Electric Motor SystemNakanishi, Inc. · 20174cite it
  • K031421Ultrasonic Scaler, Models Varios 350 Lux, Varios 350 (NO Light), Varios 550, Varios 150 Lux, Varios 150 (NO…Nakanishi, Inc. · 20043cite it
  • K132264PRIMADO2 Total Surgical SystemNakanishi, Inc. · 20133cite it
  • K112024TI-Max X450Nakanishi, Inc. · 20123cite it
  • K032395Prophy-MateNakanishi, Inc. · 20032cite it

What has FDA decided for it lately?

  • K260773Varios Combi Pro2Nakanishi, Inc. · 2026
  • K254163VarioSurg 4Nakanishi, Inc. · 2025
  • K252662UniBurNakanishi, Inc. · 2025
  • K251689Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler…Nakanishi, Inc. · 2025
  • K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)Nakanishi, Inc. · 2024
  • K233288NLZ Built-In Motor SystemNakanishi, Inc. · 2024
  • K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc. · 2024
  • K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc. · 2024

All 40 as Nakanishi, Inc. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K171155Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical…Jun 1, 2018Class II
  • K171155Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical…Jun 1, 2018Class II
  • K171155Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi…Jun 1, 2018Class II
  • K171155Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by…Jun 1, 2018Class II
  • K171155Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical…Jun 1, 2018Class II
  • K171155Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical…Jun 1, 2018Class II

Other applicant names beginning “Nakanishi”

FDA records each applicant name separately; these may or may not be the same firm.

Nakanishi Optical Products Corp. 1