Cleared Traditional

EndoVac Pure

K162436 · Kerr Corporation · Dental

Dec 2016

Decision

112d

Days

Class 1

Risk

About This 510(k) Submission

K162436 is an FDA 510(k) clearance for the EndoVac Pure, a Handpiece, Air-powered, Root Canal Irrigation (Class I — General Controls, product code NYL), submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on December 21, 2016, 112 days after receiving the submission on August 31, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K162436 FDA.gov
FDA Decision	Cleared 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

Device Classification

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