Cleared Abbreviated

K111078 - AEU-26L ELCTRONIC ENDODONTIC SYSTEM

K111078 is an FDA 510(k) clearance for AEU-26L ELCTRONIC ENDODONTIC SYSTEM, manufactured by Aseptico, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K111078 · Aseptico, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
57d
Days
Class 1
Risk

K111078 is an FDA 510(k) clearance for the AEU-26L ELCTRONIC ENDODONTIC 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 June 14, 2011 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Aseptico, Inc. devices

FDA 510(k) Submission Details - K111078

510(k) Number K111078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2011
Decision Date June 14, 2011
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 127d · This submission: 57d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 59
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K111078.
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K100600 · W&H Dentalwerk Buermoos GmbH · Jul 2010