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510(k) K052271

Device
RINSENDO
Applicant
AIR TECHNIQUES, INC.
510(k) number
K052271
Product code
NYL  
Decision
Substantially Equivalent (SESE)
Decision date
2006-05-26
Date received
2005-08-19
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH CAREY
Address
70 Cantiague Rock Rd. Hicksville NY US 11801 11801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K140685ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEMSybron Endo2014-07-02
K100606VATEA ENDONTIC IRRIGATION SYSTEMRedent Nova, Ltd.2010-05-28

Legacy Summary#

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FDA Review#

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