Cleared Traditional

K163131 - A-dec NLZ Electric Motor System (FDA 510(k) Clearance)

Class I Dental device.

K163131 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
184d
Days
Class 1
Risk

K163131 is an FDA 510(k) clearance for the A-dec NLZ Electric Motor System. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on May 11, 2017 after a review of 184 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nakanishi, Inc. devices

Submission Details

510(k) Number K163131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2016
Decision Date May 11, 2017
Days to Decision 184 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 127d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 60
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K163131.
Motor Handpiece and Control Unit (SDI10)
K251407 · Saeshin Precision Co., Ltd. · Jan 2026
Star E900 Electric System
K251701 · Dentalez, Inc., Stardental Division · Jan 2026
Motor and Apex Module (MaAM)
K251811 · Dentsply Sirona, Inc. · Aug 2025
ELEC ENGINE (Model: ISE-170L)
K231562 · Micro-Nx Co., Ltd. · Jul 2025
Dental Implant Unit
K242646 · Guilin Aesthedent Medical Instruments Co., Ltd. · Apr 2025
NLZ Built-In Motor System
K233288 · Nakanishi, Inc. · Jun 2024