Cleared Traditional

K953026 - MINIPIEZON

K953026 is an FDA 510(k) clearance for MINIPIEZON, manufactured by Electro Medical Systems SA. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K953026 · Electro Medical Systems SA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
60d
Days
Class 2
Risk

K953026 is an FDA 510(k) clearance for the MINIPIEZON. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electro Medical Systems SA devices

FDA 510(k) Submission Details - K953026

510(k) Number K953026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1995
Decision Date August 28, 1995
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
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.