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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 K071267
Device Name PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
Applicant
Novamin Technology, Inc.
13709 Progress Blvd., Suite 23
Alachua,  FL  32615
Applicant Contact ROBERT G ROTHFRITZ
Correspondent
Novamin Technology, Inc.
13709 Progress Blvd., Suite 23
Alachua,  FL  32615
Correspondent Contact ROBERT G ROTHFRITZ
Regulation Number872.3260
Classification Product Code
LBH  
Date Received05/07/2007
Decision Date 05/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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