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510(k) K830764

Device
FR ROOT CANAL SEALER
Applicant
SHIZAI CORP.
510(k) number
K830764
Product code
EKA  
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-26
Date received
1983-03-10
Regulation
872.4565
Classification name
File, Margin Finishing, Operative
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 EKA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822464OBTURATION GUTTAU.S. Shizai Corp.1982-11-03

Legacy Summary#

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FDA Review#

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