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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 K024343
Device Name BUTLER GUM PROPHY PASTE WITH NOVAMIN
Applicant
Usbiomaterials Corp.
13709 Progress Blvd., # 23
Alachua,  FL  32615
Applicant Contact DAVID C GREENSPAN
Correspondent
Usbiomaterials Corp.
13709 Progress Blvd., # 23
Alachua,  FL  32615
Correspondent Contact DAVID C GREENSPAN
Regulation Number872.6030
Classification Product Code
EJR  
Date Received12/27/2002
Decision Date 07/11/2003
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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