FDA.reportPublic FDA data

510(k) K140685

Device
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
Applicant
SYBRONENDO
510(k) number
K140685
Product code
NYL  
Decision
Substantially Equivalent (SESE)
Decision date
2014-07-02
Date received
2014-03-18
Regulation
872.4200
Classification name
Handpiece, Air-powered, Root Canal Irrigation
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
COURTNEY CLARK
Address
1717 W. Collins Ave. Orange CA US 92867 92867

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NYL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211721PS SystemInter-Med, Inc.2021-12-02
K162436EndoVac PureKerr Corporation2016-12-21
K100606VATEA ENDONTIC IRRIGATION SYSTEMRedent Nova, Ltd.2010-05-28
K052271RINSENDOAir Techniques, Inc.2006-05-26

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases