Cleared Traditional

K140685 - ENDO VAC APICAL NEGATIVE PRESSURE IRIGA...

K140685 is an FDA 510(k) clearance for ENDO VAC APICAL NEGATIVE PRESSURE IRIGA..., manufactured by Sybron Endo. The device is a Class 1 Dental device with product code NYL cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K140685 · Sybron Endo · Dental device
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Jul 2014
Decision
106d
Days
Class 1
Risk

K140685 is an FDA 510(k) clearance for the ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM. Classified as Handpiece, Air-powered, Root Canal Irrigation (product code NYL), Class I - General Controls.

Submitted by Sybron Endo (Orange, US). The FDA issued a Cleared decision on July 2, 2014 after a review of 106 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 Sybron Endo devices

FDA 510(k) Submission Details - K140685

510(k) Number K140685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date July 02, 2014
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

NYL Device Classification - Class 1, General Controls

Product Code NYL Handpiece, Air-powered, Root Canal Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
Definition To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation.
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.