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510(k) K860817

Device
ROOT CANAL ORGANIZER
Applicant
PACIFIC UNION DENTAL, INC.
510(k) number
K860817
Product code
EIK  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-17
Date received
1986-03-04
Regulation
872.4565
Classification name
Carver, Wax, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WOO, PRES.
Address
P.O. Box 2025 Silver Spring MD US 20902 20902

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013993NEOCALEXStephen M Koral, Dmd2002-02-22
K972642PERIO CONTROL IIEstrad B.V.1998-01-26
K902653PDS-2000Intl. Equipment and Supply Corp.1990-09-13
K8517272020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAArtiberia1985-07-02

Legacy Summary#

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FDA Review#

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