Cleared Traditional

Tri Auto ZX2

K170275 · J. Morita USA, Inc. · Dental
Sep 2017
Decision
224d
Days
Class 1
Risk

About This 510(k) Submission

K170275 is an FDA 510(k) clearance for the Tri Auto ZX2, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on September 11, 2017, 224 days after receiving the submission on January 30, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K170275 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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