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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 K033295
Device Name BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
Applicant
NOVAMIN TECHNOLOGY, INC.
13709 PROGRESS BLVD, # 23
ALACHUA,  FL  32615
Applicant Contact DAVID C GREENSPAN
Correspondent
N.V. KEMA
P.O. BOX 9035
6800 ET ARNHEM
ARNHEM,  NL
Correspondent Contact HARRY VAN VUGT
Regulation Number872.3260
Classification Product Code
LBH  
Date Received10/14/2003
Decision Date 10/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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