Cleared Traditional

K123139 - ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES

K123139 is an FDA 510(k) clearance for ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES, manufactured by Asi Medical, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K123139 · Asi Medical, Inc. · Dental device
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Mar 2013
Decision
174d
Days
Class 2
Risk

K123139 is an FDA 510(k) clearance for the ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Asi Medical, Inc. (Centennial, US). The FDA issued a Cleared decision on March 28, 2013 after a review of 174 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 Asi Medical, Inc. devices

FDA 510(k) Submission Details - K123139

510(k) Number K123139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2012
Decision Date March 28, 2013
Days to Decision 174 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 127d · This submission: 174d
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 99
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K123139.
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ULTRASONIC SCALER
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K113430 · Satelec - Acteon Group · Feb 2012