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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K983751
Device Name QUADRANT UNICHEM
Applicant
Cavex Holland BV
Harmenjansweg 21
Haarlem,  NL 2031 WH
Applicant Contact BERNARD VAN DUIJN
Correspondent
Cavex Holland BV
Harmenjansweg 21
Haarlem,  NL 2031 WH
Correspondent Contact BERNARD VAN DUIJN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/23/1998
Decision Date 11/30/1998
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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