Cleared Traditional

K173465 - Concentrix MX-AC High-Speed Handpiece

K173465 is the FDA 510(k) clearance for Concentrix MX-AC High-Speed Handpiece by Dentalez, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K173465 · Dentalez, Inc. · Dental device
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Mar 2018
Decision
140d
Days
Class 1
Risk

K173465 is an FDA 510(k) clearance for the Concentrix MX-AC High-Speed Handpiece. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentalez, Inc. (Lancaster, US). The FDA issued a Cleared decision on March 28, 2018 after a review of 140 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 Dentalez, Inc. devices

Submission Details

510(k) Number K173465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2017
Decision Date March 28, 2018
Days to Decision 140 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
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 66
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K173465.
PROPHYflex 4
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BOSWORTH AIR POLISHER
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CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009