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510(k) K060347

Device
B&L L-BETA, MODEL WL-B1
Applicant
B&L Biotech Co., Ltd.
510(k) number
K060347
Product code
EKR
Decision
Substantially Equivalent (SESE)
Decision date
2006-06-05
Date received
2006-02-10
Regulation
872.4565
Classification name
Plugger, Root Canal, Endodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DANIEL KAMM
Address
P.O. Box 7007 Deer Field IL US 60015 60015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EKR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K831748ENDODONTIC ROOT CANAL PLUGGER FINGER-Union Branch1983-07-12
K791019MCSPADDEN CONDENSORTechdent, Inc.1979-08-03