FDA.reportPublic FDA data

510(k) K780746

Device
HYGIENIC RUBBER DAM FRAME
Applicant
HYGIENIC DENTAL MFG., CO., THE
510(k) number
K780746
Product code
EJE  
Decision
Substantially Equivalent (SESE)
Decision date
1978-05-12
Date received
1978-04-13
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
K781520RUBBER DAM HOLDERYoung Dental Manufacturing Co. 1, LLC1978-10-10
K770117HYGIENIC 5 & 6 RUBBER DAM FRAMEHygienic Dental Mfg., Co., The1977-01-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases