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510(k) K930335

Device
PROFAST - DENTURE ADHESIVE FOR LOWER JAWS
Applicant
FITTYDENT-ALTWIRTH & SCHMITT GMBH
510(k) number
K930335
Product code
KOO  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-01
Date received
1993-01-22
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
THOMAS J MULDOON
Address
333 W. Wacler Dr. Siote 2600 Chicago IL US 60606 60606

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
K943486ORAFIX SPECIAL DENTURE ADHESIVESmithkline Beecham Corp.1994-11-03
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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