Cleared Traditional

K970339 - TRI AUTO ZX

K970339 is an FDA 510(k) clearance for TRI AUTO ZX, 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 126-day FDA review.

K970339 · J. Morita USA, Inc. · Dental device
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Jun 1997
Decision
126d
Days
Class 1
Risk

K970339 is an FDA 510(k) clearance for the TRI AUTO ZX. 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 June 4, 1997 after a review of 126 days - within the typical 510(k) review window.

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 - K970339

510(k) Number K970339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1997
Decision Date June 04, 1997
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 127d · This submission: 126d
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 Peers - EKX Handpiece, Direct Drive, Ac-powered

All 69
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