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510(k) K821364

Device
PROFLEX FLEXIBLE SCALER
Applicant
TELEDYNE DENSCO
510(k) number
K821364
Product code
EHM  
Decision
Substantially Equivalent (SESE)
Decision date
1982-05-28
Date received
1982-05-07
Regulation
872.6010
Classification name
Strip, Polishing Agent
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 EHM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K790598RUWA FINISHING STRIPSHowmedica Corp.1979-05-21

Legacy Summary#

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FDA Review#

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