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510(k) K211721

Device
PS System
Applicant
Inter-Med, INC.
510(k) number
K211721
Product code
NYL  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-02
Date received
2021-06-04
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
Brett Arand
Address
2200 S. St. Racine WI US 53404 53404

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
K162436EndoVac PureKerr Corporation2016-12-21
K140685ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEMSybron Endo2014-07-02
K100606VATEA ENDONTIC IRRIGATION SYSTEMRedent Nova, Ltd.2010-05-28
K052271RINSENDOAir Techniques, Inc.2006-05-26

Legacy Summary#

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FDA Review#

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