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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 K980539
Device Name SOLOBOND M
Applicant
Voco GmbH
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN DICK, PH.D.
Correspondent
Voco GmbH
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN DICK, PH.D.
Regulation Number872.3200
Classification Product Code
KLE  
Date Received02/12/1998
Decision Date 03/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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