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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K070215
Device Name TOKUYAMA BOND FORCE
Applicant
TOKUYAMA DENTAL CORPORATION
1425 K STREET, N.W. SUITE 1100
WASHINGTON,  DC  20005
Applicant Contact ROBERT A SILVERMAN
Correspondent
TOKUYAMA DENTAL CORPORATION
1425 K STREET, N.W. SUITE 1100
WASHINGTON,  DC  20005
Correspondent Contact ROBERT A SILVERMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received01/23/2007
Decision Date 03/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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