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510(k) K972642

Device
PERIO CONTROL II
Applicant
ESTRAD B.V.
510(k) number
K972642
Product code
EIK  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-26
Date received
1997-07-15
Regulation
872.4565
Classification name
Carver, Wax, Dental
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 EIK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013993NEOCALEXStephen M Koral, Dmd2002-02-22
K902653PDS-2000Intl. Equipment and Supply Corp.1990-09-13
K860817ROOT CANAL ORGANIZERPacific Union Dental, Inc.1986-03-17
K8517272020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAArtiberia1985-07-02

Legacy Summary#

summary

FDA Review#

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