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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 K984043
Device Name QUADRANT TOTAL ETCH
Applicant
Cavex Holland BV
2003 Rw Haarlem
P.O. Box 852
Harmen,  NL 19-21
Applicant Contact BERNARD VAN DUIJN
Correspondent
Cavex Holland BV
2003 Rw Haarlem
P.O. Box 852
Harmen,  NL 19-21
Correspondent Contact BERNARD VAN DUIJN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/13/1998
Decision Date 12/04/1998
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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