Cleared Traditional

K140990 - EMS PIEZON 707 BIK AND PIEZON 707 BIK LED

K140990 is an FDA 510(k) clearance for EMS PIEZON 707 BIK AND PIEZON 707 BIK LED, 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 316-day FDA review.

K140990 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
316d
Days
Class 2
Risk

K140990 is an FDA 510(k) clearance for the EMS PIEZON 707 BIK AND PIEZON 707 BIK LED. 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 February 27, 2015 after a review of 316 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 - K140990

510(k) Number K140990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2014
Decision Date February 27, 2015
Days to Decision 316 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
189d slower than avg
Panel avg: 127d · This submission: 316d
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 K140990.
Cavitron Touch Ultrasonic Scaling System
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K143448 · Sonendo, Inc. · May 2015
ULTRASONIC SCALER
K140233 · Nanning Baolai Medical Instrument Co., Ltd. · Apr 2015
MULTIPIEZO PRO, MULTIPIEZO
K140965 · Mectron S.P.A. · Aug 2014
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
K133752 · Sonendo, Inc. · May 2014
NEWTRON P5 XS B.LED
K132322 · Satelec - Acteon Group · Mar 2014