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510(k) K781520

Device
RUBBER DAM HOLDER
Applicant
YOUNG DENTAL MANUFACTURING CO 1, LLC.
510(k) number
K781520
Product code
EJE  
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-10
Date received
1978-09-01
Regulation
872.6300
Classification name
Frame, Rubber Dam
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 EJE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K780746HYGIENIC RUBBER DAM FRAMEHygienic Dental Mfg., Co., The1978-05-12
K770117HYGIENIC 5 & 6 RUBBER DAM FRAMEHygienic Dental Mfg., Co., The1977-01-28

Legacy Summary#

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FDA Review#

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