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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Manual
510(k) Number K102871
Device Name SILVER CARE ANITBACTERIAL TOOTHBRUSH
Applicant
Piave Spazzolificio S.P.A.
212 W 91st St.
Apt. 812
New York,  NY  10024
Applicant Contact KEILA LACOURT
Correspondent
Piave Spazzolificio S.P.A.
212 W 91st St.
Apt. 812
New York,  NY  10024
Correspondent Contact KEILA LACOURT
Regulation Number872.6855
Classification Product Code
EFW  
Date Received09/30/2010
Decision Date 10/03/2011
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
Recalls CDRH Recalls
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