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510(k) K941365

Device
MPI DENTURE ADHESIVE FILM SEALS
Applicant
MEDICAL POLYMERS, INC.
510(k) number
K941365
Product code
KOT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-22
Date received
1994-03-21
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
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS VANNE
Address
8920 Business Park Dr. Suite 290 Austin TX US 78759 78759

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
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
K854430RIGIDENT CREAMArmkel, LLC1986-03-04
K831493DENTURE ADHESIVE SEALSJohnson & Johnson Professionals, Inc.1983-06-30

Legacy Summary#

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FDA Review#

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