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510(k) K854430

Device
RIGIDENT CREAM
Applicant
ARMKEL, LLC.
510(k) number
K854430
Product code
KOT  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-04
Date received
1985-11-05
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
STEPHEN KOLAKOSKY
Address
Half Acre Rd. P.O. Box 1001 Cranbury NJ US 08512 08512

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
K903568SUPER STRENGTH DENTURE ADHESIVE CREAMTeledyne Getz1990-10-24
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
K831493DENTURE ADHESIVE SEALSJohnson & Johnson Professionals, Inc.1983-06-30

Legacy Summary#

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FDA Review#

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