Cleared Traditional

K091065 - AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4

K091065 is an FDA 510(k) clearance for AIR TORX, manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K091065 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
185d
Days
Class 1
Risk

K091065 is an FDA 510(k) clearance for the AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on October 16, 2009 after a review of 185 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 - K091065

510(k) Number K091065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2009
Decision Date October 16, 2009
Days to Decision 185 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
58d slower than avg
Panel avg: 127d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
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 - EFB Handpiece, Air-powered, Dental

All 163
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K091065.
BOSWORTH AIR POLISHER
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K082791 · E.M.S Electro Medical Systems S.A · Feb 2009
CARE3 PLUS
K081811 · Nakanishi, Inc. · Jan 2009