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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 K983545
Device Name QUADRANT UNIBOND
Applicant
CAVEX HOLLAND B.V.
PO BOX 852
RW HAARLEM (HOLLAND),  NL 2003
Applicant Contact BERNARD VAN DUIJIN
Correspondent
CAVEX HOLLAND B.V.
PO BOX 852
RW HAARLEM (HOLLAND),  NL 2003
Correspondent Contact BERNARD VAN DUIJIN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/09/1998
Decision Date 11/18/1998
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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