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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 K973245
Device Name TOKUSO REBASE MR. BOND
Applicant
Tokuyama America, Inc.
1233 20th., NW #700
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Tokuyama America, Inc.
1233 20th., NW #700
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/29/1997
Decision Date 10/07/1997
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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