Cleared Traditional

K123139 - ADVANCED ENDODONTIC SYSTEM- DESIGNER SE...

K123139 is the FDA 510(k) clearance for ADVANCED ENDODONTIC SYSTEM- DESIGNER SE... by Asi Medical, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

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 Peers - ELC Scaler, Ultrasonic

All 46
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