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510(k) K780528

Device
PREMIER CARVERS, STYLE #21C & 21D
Applicant
PREMIER DENTAL PRODUCTS CO.
510(k) number
K780528
Product code
EKH  
Decision
Substantially Equivalent (SESE)
Decision date
1978-04-19
Date received
1978-04-03
Regulation
872.4565
Classification name
Carver, Dental Amalgam, 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 EKH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823321DENTAL INSTRUMENTS - CARVERMiltex, Inc.1982-11-24
K821785BEACH AMALGAM CARVERPacific Dental Corp.1982-07-06

Legacy Summary#

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FDA Review#

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