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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Denture, Over The Counter
510(k) Number K051342
Device Name MEDICAL INTERPOROUS
Applicant
Bonyf AG
67 Main St.
Silver Creek,  NY  14136
Applicant Contact DONNA MARIE HARTNETT
Correspondent
Bonyf AG
67 Main St.
Silver Creek,  NY  14136
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.3520
Classification Product Code
EFT  
Date Received05/23/2005
Decision Date 06/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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