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510(k) K945220

Device
AMALGAM CARRIER
Applicant
BUFFALO DENTAL MFG. CO., INC.
510(k) number
K945220
Product code
EKI  
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-11
Date received
1994-10-26
Regulation
872.4565
Classification name
Carrier, Amalgam, Operative
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DONVIN M NEVIN
Address
99 Lafayette Dr. Syosset NY US 11791 11791

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EKI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K781034PREMIER INLAY PLACERPremier Dental Products Co.1978-06-30

Legacy Summary#

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FDA Review#

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