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)
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.

View all Osstell AB devices

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
124d slower than avg
Panel avg: 127d · 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 69
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