Cleared Traditional

K132609 - EDS ULTRASONIC TIPS

K132609 is an FDA 510(k) clearance for EDS ULTRASONIC TIPS, manufactured by Essential Dental Systems, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K132609 · Essential Dental Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
155d
Days
Class 2
Risk

K132609 is an FDA 510(k) clearance for the EDS ULTRASONIC TIPS. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 155 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 Essential Dental Systems, Inc. devices

FDA 510(k) Submission Details - K132609

510(k) Number K132609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2013
Decision Date January 22, 2014
Days to Decision 155 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
28d slower than avg
Panel avg: 127d · This submission: 155d
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 75
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