FDA.reportPublic FDA data

510(k) K943486

Device
ORAFIX SPECIAL DENTURE ADHESIVE
Applicant
SMITHKLINE BEECHAM CORP.
510(k) number
K943486
Product code
KOO  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-03
Date received
1994-07-19
Regulation
872.3490
Classification name
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANTHONY G AMITRANO
Address
1500 Littleton Rd. Parsippany NJ US 07054 07054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KOO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945200FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCESProcter & Gamble Co.1994-11-30
K930335PROFAST - DENTURE ADHESIVE FOR LOWER JAWSFittydent-Altwirth & Schmitt GmbH1994-02-01
K862876NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAMBlock Drug Company, Inc.1986-08-29

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