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510(k) K945200

Device
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
Applicant
PROCTER & GAMBLE CO.
510(k) number
K945200
Product code
KOO  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-30
Date received
1994-10-25
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
RANDALL A STOLT
Address
Sharon Woods Technical Centter 11450 Grooms Rd. Cincinnati OH US 45242 45242

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KOO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943486ORAFIX SPECIAL DENTURE ADHESIVESmithkline Beecham Corp.1994-11-03
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#

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FDA Review#

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