Cleared Traditional

K191079 - Piezon Built-in Kit

K191079 is the FDA 510(k) clearance for Piezon Built-in Kit 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 115-day FDA review.

K191079 · E.M.S Electro Medical Systems S.A · Dental device
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
115d
Days
Class 2
Risk

K191079 is an FDA 510(k) clearance for the Piezon Built-in Kit, Piezon Built-in Kit LED. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on August 16, 2019 after a review of 115 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. 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 K191079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2019
Decision Date August 16, 2019
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
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 Consultant

Ultra Life Science Solutions, Inc.
Christina Henza

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ELC Scaler, Ultrasonic

All 56
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