Cleared Special

K132401 - MEGA ISQ

K132401 is an FDA 510(k) clearance for MEGA ISQ, manufactured by Osstell AB. The device is a Class 1 Dental device with product code EKX cleared through the Special 510(k) pathway after a 251-day FDA review.

K132401 · Osstell AB · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
251d
Days
Class 1
Risk

K132401 is an FDA 510(k) clearance for the MEGA ISQ. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Osstell AB (Alexandria, US). The FDA issued a Cleared decision on April 9, 2014 after a review of 251 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132401

510(k) Number K132401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2013
Decision Date April 09, 2014
Days to Decision 251 days
Submission Type Special
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
123d slower than avg
Panel avg: 128d · This submission: 251d
Pathway characteristics
Modification to existing cleared device.

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 89
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K132401.
Osstell IDx
K142358 · Osstell AB · Feb 2015
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
K142124 · Aseptico, Inc. · Dec 2014
ENDO SMART
K133298 · Meta Biomed, Inc. · Sep 2014
IPROPHY MOBILE
K131578 · Nakanishi, Inc. · Sep 2013
ENDO A CLASS
K123582 · Saeyang Microtech Co., Ltd. · Aug 2013
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
K112665 · J. Morita USA, Inc. · May 2012
K132401 · MEGA ISQ
Download PDF FDA Summary Osstell AB