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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 K041371
Device Name BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
Applicant
Novamin Technology, Inc.
13709 Progress Blvd., # 23
Alachua,  FL  32615
Applicant Contact DAVID C GREENSPAN
Correspondent
Novamin Technology, Inc.
13709 Progress Blvd., # 23
Alachua,  FL  32615
Correspondent Contact DAVID C GREENSPAN
Regulation Number872.6030
Classification Product Code
EJR  
Date Received05/24/2004
Decision Date 08/23/2004
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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