Cleared Traditional

K142124 - AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM

K142124 is an FDA 510(k) clearance for AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM, manufactured by Aseptico, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K142124 · Aseptico, Inc. · Dental device
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Dec 2014
Decision
149d
Days
Class 1
Risk

K142124 is an FDA 510(k) clearance for the AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Aseptico, Inc. (Woodinville, US). The FDA issued a Cleared decision on December 31, 2014 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Aseptico, Inc. devices

FDA 510(k) Submission Details - K142124

510(k) Number K142124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2014
Decision Date December 31, 2014
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 59
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