Cleared Traditional

K170275 - Tri Auto ZX2

K170275 is an FDA 510(k) clearance for Tri Auto ZX2, manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K170275 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
224d
Days
Class 1
Risk

K170275 is an FDA 510(k) clearance for the Tri Auto ZX2. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on September 11, 2017 after a review of 224 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 J. Morita USA, Inc. devices

FDA 510(k) Submission Details - K170275

510(k) Number K170275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2017
Decision Date September 11, 2017
Days to Decision 224 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 127d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
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 Consultant

Fish & Richardson, P.C.
KEITH A. BARRITT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 69
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K170275.
LS OIL
K173920 · J. Morita USA, Inc. · Oct 2018
Young INFINITY Cordless Handpiece System
K171377 · Young Dental Manufacturing Co. 1, LLC · Aug 2018
IS3
K180527 · Hiossen, Inc. · May 2018
MEG-TORQ
K161500 · Micro-Nx Co., Ltd. · Feb 2017
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
K160825 · Dentsply Sirona · Sep 2016
EMS-200
K153285 · Meta Systems Co., Ltd. · Aug 2016