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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 K100172
Device Name TOKUYAMA SHIELD FORCE
Applicant
TOKUYAMA DENTAL CORPORATION
1425 K STREET, N.W. SUITE 1100
WASHINGTON,  DC  20005
Applicant Contact KEITH BARRITT
Correspondent
TOKUYAMA DENTAL CORPORATION
1425 K STREET, N.W. SUITE 1100
WASHINGTON,  DC  20005
Correspondent Contact KEITH BARRITT
Regulation Number872.3260
Classification Product Code
LBH  
Date Received01/21/2010
Decision Date 10/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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