510(k) K803155

Device
PROPHYLAXIS CUP.
Applicant
TELEDYNE DENSCO
510(k) number
K803155
Product code
EHK  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-08
Date received
1980-12-12
Regulation
872.6290
Classification name
Cup, Prophylaxis
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 EHK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953628PROPHY ANGLERolence Enterprise Co. , Ltd.1995-09-29
K951016DISPOSABLE PROPHYLAXIS ANGLEPreventive Technologies, Inc.1995-05-02
K900507DISPOSABLE SCREW TYPE PROPHY BRUSHDentsply Intl.1990-04-10
K864059DENTAL PROPHY CUPS (VARIOUS TYPES)Mission White Dental, Inc.1986-11-19
K790723PROPHYLAXIS CUPS AND POLISHERSYoung Dental Manufacturing Co. 1, LLC1979-06-15
K780198PROPHY CUPS, R&RRansom and Randolph1978-02-16
K770556PRO-KUPDental Control Products1977-03-24

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