Cleared Traditional

K111541 - ENDO-EXPRESS (R) HANDPIECE (FDA 510(k) Clearance)

Class I Dental device.

K111541 · Essential Dental Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
288d
Days
Class 1
Risk

K111541 is an FDA 510(k) clearance for the ENDO-EXPRESS (R) HANDPIECE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on March 16, 2012 after a review of 288 days - an extended review cycle.

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 Essential Dental Systems, Inc. devices

Submission Details

510(k) Number K111541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2011
Decision Date March 16, 2012
Days to Decision 288 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
161d slower than avg
Panel avg: 127d · This submission: 288d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 72
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