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510(k) K780560

Device
DENTAL AMALGAMATOR
Applicant
L.D. CAULK CO.
510(k) number
K780560
Product code
EFD  
Decision
Substantially Equivalent (SESE)
Decision date
1978-04-21
Date received
1978-04-05
Regulation
872.3100
Classification name
Amalgamator, Dental, Ac-powered
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EFD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991913PENTAMIX 2Espe Dental AG1999-07-26
K923974SILIMAT PLUSIvoclar North America, Inc.1992-10-06
K922203IPT CAPSULE MIXERIpt Technologies, Inc.1992-06-03
K915847AUTOMIX DENTAL AMALGAMATORKerr Corporation (Danbury)1992-03-02
K914340DUOMAT 3 AMALGAMATORDegussa AG1991-11-13
K914341MIXOMAT AMALGAMATORDegussa AG1991-11-13
K914339DENTOMAT 3 AMALGAMATORSDegussa AG1991-11-07
K910632ACCU-MIX AMALGAMATORWykle Research, Inc.1991-03-15
K901909SILAMAT (AMALGAMATOR)Ivoclar North America, Inc.1990-06-22
K891612DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.Implant Innovations International, Inc.1989-06-12
K891064ESPE CAPMIXEspe GmbH (Us)1989-05-30
K880993AMALGAMATORAcecodent, Inc.1988-05-11
K791410AMALGAMATOR MODEL SDC--Sierra Laboratories, Inc.1979-09-19
K771901CAPMIXEspe Dental Products1977-10-20

Legacy Summary#

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FDA Review#

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