Cleared Special

K082523 - OSSTELL ISQ IMPLANT STABILITY METER

K082523 is an FDA 510(k) clearance for OSSTELL ISQ IMPLANT STABILITY METER, 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 24-day FDA review.

K082523 · Osstell AB · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
24d
Days
Class 1
Risk

K082523 is an FDA 510(k) clearance for the OSSTELL ISQ IMPLANT STABILITY METER. 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 September 26, 2008 after a review of 24 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K082523

510(k) Number K082523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date September 26, 2008
Days to Decision 24 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
104d faster than avg
Panel avg: 128d · This submission: 24d
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 K082523.
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K082523 · OSSTELL ISQ IMPLANT STABILITY METER
Download PDF FDA Summary Osstell AB