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510(k) K781034

Device
PREMIER INLAY PLACER
Applicant
PREMIER DENTAL PRODUCTS CO.
510(k) number
K781034
Product code
EKI  
Decision
Substantially Equivalent (SESE)
Decision date
1978-06-30
Date received
1978-06-19
Regulation
872.4565
Classification name
Carrier, 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 EKI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945220AMALGAM CARRIERBuffalo Dental Mfg. Co., Inc.1995-01-11

Legacy Summary#

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FDA Review#

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