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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name varnish, cavity
510(k) Number K073061
Device Name THE PROXIVENT KIT
Applicant
COLL PARTNERS LTD.
POB 6718
EFRAT,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
COLL PARTNERS LTD.
POB 6718
EFRAT,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number872.3260
Classification Product Code
LBH  
Date Received10/30/2007
Decision Date 02/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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