510(k) K770117

Device: HYGIENIC 5 & 6 RUBBER DAM FRAME
Applicant: Hygienic Dental Mfg., Co., The
510(k) number: K770117
Product code: EJE
Decision: Substantially Equivalent (SESE)
Decision date: 1977-01-28
Date received: 1977-01-21
Regulation: 872.6300
Classification name: Frame, Rubber Dam
Medical specialty: Dental
Review panel: Dental
Device class: 1
Clearance type: Traditional
Third party reviewed: N

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)	Device	Applicant	Decision date
K781520	RUBBER DAM HOLDER	Young Dental Manufacturing Co. 1, LLC	1978-10-10
K780746	HYGIENIC RUBBER DAM FRAME	Hygienic Dental Mfg., Co., The	1978-05-12