Cleared Traditional

K112665 - TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE

K112665 is an FDA 510(k) clearance for TRI AUTO MINI - ENDODEONTIC TREATMENT M..., 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 234-day FDA review.

K112665 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
234d
Days
Class 1
Risk

K112665 is an FDA 510(k) clearance for the TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE. 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 May 4, 2012 after a review of 234 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 - K112665

510(k) Number K112665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2011
Decision Date May 04, 2012
Days to Decision 234 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
107d slower than avg
Panel avg: 127d · This submission: 234d
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 K112665.
MEGA ISQ
K132401 · Osstell AB · Apr 2014
IPROPHY MOBILE
K131578 · Nakanishi, Inc. · Sep 2013
ENDO A CLASS
K123582 · Saeyang Microtech Co., Ltd. · Aug 2013
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
K110278 · Nakanishi, Inc. · Feb 2012
E-CUBE
K111616 · Saeshin Precision Co., Ltd. · Aug 2011
AEU-26L ELCTRONIC ENDODONTIC SYSTEM
K111078 · Aseptico, Inc. · Jun 2011