FDA.reportPublic FDA data

510(k) K903568

Device
SUPER STRENGTH DENTURE ADHESIVE CREAM
Applicant
TELEDYNE GETZ
510(k) number
K903568
Product code
KOT  
Decision
Substantially Equivalent (SESE)
Decision date
1990-10-24
Date received
1990-08-07
Regulation
872.3490
Classification name
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GABRIEL LEBOVIC
Address
1550 Greenleaf Ave. Elk Grove Village IL US 60007 60007

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KOT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945462SUPER POLI-GRIP DENTURE ADHESIVE CREAMBlock Drug Company, Inc.1994-12-20
K941365MPI DENTURE ADHESIVE FILM SEALSMedical Polymers, Inc.1994-04-22
K895818STEADFAST DENTURE ADHESIVE CREAMStiefel Research Institute, Inc.1990-04-03
K884357PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEMPrecision Dynamics Corp.1988-11-01
K872225SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDERBlock Drug Company, Inc.1987-06-30
K854430RIGIDENT CREAMArmkel, LLC1986-03-04
K831493DENTURE ADHESIVE SEALSJohnson & Johnson Professionals, Inc.1983-06-30

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