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510(k) K831748

Device
ENDODONTIC ROOT CANAL PLUGGER FINGER-
Applicant
UNION BRANCH
510(k) number
K831748
Product code
EKR  
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-12
Date received
1983-05-23
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#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K860569ENDODONTIC ROOT CANAL PLUGGERDentsply Intl.1986-03-26
K791019MCSPADDEN CONDENSORTechdent, Inc.1979-08-03

Legacy Summary#

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FDA Review#

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