Cleared Special

K022328 - EMS PIEZON MASTER 600

K022328 is an FDA 510(k) clearance for EMS PIEZON MASTER 600, manufactured by Electro Medical Systems SA. The device is a Class 2 Dental device with product code ELC cleared through the Special 510(k) pathway after a 26-day FDA review.

K022328 · Electro Medical Systems SA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
26d
Days
Class 2
Risk

K022328 is an FDA 510(k) clearance for the EMS PIEZON MASTER 600. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on August 13, 2002 after a review of 26 days - a notably fast clearance cycle.

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. 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.

View all Electro Medical Systems SA devices

FDA 510(k) Submission Details - K022328

510(k) Number K022328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2002
Decision Date August 13, 2002
Days to Decision 26 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 127d · This submission: 26d
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 115
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K022328.
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