Cleared Special

K132445 - PIEZON 250

K132445 is an FDA 510(k) clearance for PIEZON 250, manufactured by E.M.S Electro Medical Systems S.A. The device is a Class 2 Dental device with product code ELC cleared through the Special 510(k) pathway after a 122-day FDA review.

K132445 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
122d
Days
Class 2
Risk

K132445 is an FDA 510(k) clearance for the PIEZON 250. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by E.M.S Electro Medical Systems S.A (Marlborough, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 - K132445

510(k) Number K132445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2013
Decision Date December 06, 2013
Days to Decision 122 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
6d faster than avg
Panel avg: 128d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 194
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K132445 · PIEZON 250
Download PDF FDA Summary E.M.S Electro Medical…