Cleared Traditional

K093000 - EMS PIEZON MASTER 700

K093000 is an FDA 510(k) clearance for EMS PIEZON MASTER 700, 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 Traditional 510(k) pathway after a 305-day FDA review.

K093000 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
305d
Days
Class 2
Risk

K093000 is an FDA 510(k) clearance for the EMS PIEZON MASTER 700. 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 July 30, 2010 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K093000

510(k) Number K093000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date July 30, 2010
Days to Decision 305 days
Submission Type Traditional
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
178d slower than avg
Panel avg: 127d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 123
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K093000.
EMS AIR-FLOW MASTER PIEZON
K110173 · E.M.S Electro Medical Systems S.A · Apr 2011
LAKONG ULTRASONIC SCALER
K103498 · Lakong Medical Device Company, Ltd. · Mar 2011
EMS MINIMASTER LED
K093723 · E.M.S Electro Medical Systems S.A · Sep 2010
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