Cleared Traditional

K133170 - QUICK JET M

K133170 is an FDA 510(k) clearance for QUICK JET M, manufactured by Micron Corp.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K133170 · Micron Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
162d
Days
Class 1
Risk

K133170 is an FDA 510(k) clearance for the QUICK JET M. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Micron Corp. (Ota-Ku, Tokyo, JP). The FDA issued a Cleared decision on March 28, 2014 after a review of 162 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.

FDA 510(k) Submission Details - K133170

510(k) Number K133170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date March 28, 2014
Days to Decision 162 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
34d slower than avg
Panel avg: 128d · This submission: 162d
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 237
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K133170.
CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
K133069 · Codent Technical Industry Co., Ltd. · Oct 2014
T1/T2/T3 TURBINE FAMILY
K131319 · Sirona Dental Systems GmbH · May 2014
AIR-FLOW HANDY 3.0
K132478 · E.M.S Electro Medical Systems S.A · Apr 2014
AIR-FLOW HANDY 3.0 PERIO
K132480 · E.M.S Electro Medical Systems S.A · Feb 2014
MASTERTORQUE LUX 8900 L
K130560 · Kaltenbach & Voigt GmbH · Sep 2013
430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
K130455 · Dentalez Group, Stardental Division · Sep 2013
K133170 · QUICK JET M
Download PDF FDA Summary Micron Corp.