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510(k) K860569

Device
ENDODONTIC ROOT CANAL PLUGGER
Applicant
DENTSPLY INTL.
510(k) number
K860569
Product code
EKR  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-26
Date received
1986-02-11
Regulation
872.4565
Classification name
Plugger, Root Canal, Endodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN O SEMMELMAN
Address
570 W. College Ave. P.O. Box 872 York PA US 17405 17405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EKR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060347B&L L-BETA, MODEL WL-B1B&L Biotech Co., Ltd.2006-06-05
K042828OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700Young O/S, LLC2004-12-01
K031664ELEMENTS OBTURATION UNITSybron Endo/Analytic2004-04-28
K831748ENDODONTIC ROOT CANAL PLUGGER FINGER-Union Branch1983-07-12
K791019MCSPADDEN CONDENSORTechdent, Inc.1979-08-03

Legacy Summary#

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FDA Review#

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