Cleared Traditional

K112665 - TRI AUTO MINI - ENDODEONTIC TREATMENT M...

K112665 is the FDA 510(k) clearance for TRI AUTO MINI - ENDODEONTIC TREATMENT M... by J. Morita USA, Inc.. It is a Class 1 Dental device (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

Submission Details

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.

Device Classification

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 45
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