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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 K003153
Device Name SOLOBOND PLUS
Applicant
VOCO GMBH
7527 WESTMORELAND AVE.
ST. LOUIS,  MO  63105
Applicant Contact EVAN DICK
Correspondent
VOCO GMBH
7527 WESTMORELAND AVE.
ST. LOUIS,  MO  63105
Correspondent Contact EVAN DICK
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/10/2000
Decision Date 11/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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