Cleared Traditional

K071190 - ROOT ZX II

K071190 is an FDA 510(k) clearance for ROOT ZX II, 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 109-day FDA review.

K071190 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
109d
Days
Class 1
Risk

K071190 is an FDA 510(k) clearance for the ROOT ZX II. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on August 17, 2007 after a review of 109 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 - K071190

510(k) Number K071190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date August 17, 2007
Days to Decision 109 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
18d faster than avg
Panel avg: 127d · This submission: 109d
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
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K071190.
GENERAL DENISTRY MOTOR
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K090931 · W&H Dentalwerk Buermoos GmbH · Dec 2009
SIROENDO
K052515 · Sirona Dental Systems GmbH · Mar 2006
IMPLANT HANDPIECES
K051661 · Sirona Dental Systems GmbH · Sep 2005
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
K050612 · Lightspeed Technology, Inc. · May 2005