Cleared Traditional

K896749 - PIEZON MASTER 400

K896749 is an FDA 510(k) clearance for PIEZON MASTER 400, manufactured by Electro Medical Systems (Ems Sa). The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K896749 · Electro Medical Systems (Ems Sa) · Dental device
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Aug 1990
Decision
274d
Days
Class 2
Risk

K896749 is an FDA 510(k) clearance for the PIEZON MASTER 400. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Electro Medical Systems (Ems Sa) (Nyon, CH). The FDA issued a Cleared decision on August 31, 1990 after a review of 274 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 Electro Medical Systems (Ems Sa) devices

FDA 510(k) Submission Details - K896749

510(k) Number K896749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1989
Decision Date August 31, 1990
Days to Decision 274 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 127d · This submission: 274d
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 141
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K896749.
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SONIC SCALER
K902413 · Dentsply Intl. · Aug 1990
PERIODONTAL IRRIGATING SOLUTION-D
K894247 · Dentsply Intl. · Oct 1989
ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · Dentsply Intl. · Feb 1987