Cleared Traditional

K162436 - EndoVac Pure

K162436 is an FDA 510(k) clearance for EndoVac Pure, manufactured by Kerr Corporation. The device is a Class 1 Dental device with product code NYL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K162436 · Kerr Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
112d
Days
Class 1
Risk

K162436 is an FDA 510(k) clearance for the EndoVac Pure. Classified as Handpiece, Air-powered, Root Canal Irrigation (product code NYL), Class I - General Controls.

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on December 21, 2016 after a review of 112 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.

FDA 510(k) Submission Details - K162436

510(k) Number K162436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2016
Decision Date December 21, 2016
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 128d · This submission: 112d
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.

Regulatory Consultant

Sybron Dental Specialties
Mohammad Saad Ansari

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 - NYL Handpiece, Air-powered, Root Canal Irrigation

Devices cleared under the same product code (NYL) and FDA review panel - the closest regulatory comparables to K162436.
EndoColibri
K260356 · Koehrer Medical Engineering GmbH · Oct 2026
PS System
K211721 · Inter-Med, Inc. · Dec 2021
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
K140685 · Sybron Endo · Jul 2014
VATEA ENDONTIC IRRIGATION SYSTEM
K100606 · Redent-Nova , Ltd. · May 2010
RINSENDO
K052271 · Air Techniques, Inc. · May 2006
K162436 · EndoVac Pure
Download PDF FDA Summary Kerr Corporation