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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K103114
Device Name OSSPRAY SYLC CR
Applicant
Osspray, Ltd.
Hodgkin Bldg.
Kings College London
London,  GB SE1 1UL
Applicant Contact IAN THOMPSON
Correspondent
Osspray, Ltd.
Hodgkin Bldg.
Kings College London
London,  GB SE1 1UL
Correspondent Contact IAN THOMPSON
Regulation Number872.6030
Classification Product Code
EJR  
Date Received10/21/2010
Decision Date 03/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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