Cleared Traditional

K093723 - EMS MINIMASTER LED

K093723 is the FDA 510(k) clearance for EMS MINIMASTER LED by E.M.S Electro Medical Systems S.A. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K093723 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
279d
Days
Class 2
Risk

K093723 is an FDA 510(k) clearance for the EMS MINIMASTER LED. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by E.M.S Electro Medical Systems S.A (North Attleboro, US). The FDA issued a Cleared decision on September 8, 2010 after a review of 279 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all E.M.S Electro Medical Systems S.A devices

Submission Details

510(k) Number K093723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2009
Decision Date September 08, 2010
Days to Decision 279 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 127d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K093723.
Cavitron Touch Ultrasonic Scaling System
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ULTRASONIC SCALER
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ULTRASONIC SCALER
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A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
K100647 · A-Dec, Inc. · Jul 2010
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
K080089 · Sybron Dental Specialties, Inc. · Sep 2008
VARIOS 75
K071447 · Nakanishi, Inc. · Apr 2008