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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K980965
Device Name SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL
Applicant
Cavex Holland BV
2003 Rw Haarlem
P.O. Box 852
Harmen,  NL 19-21
Applicant Contact BERNARD VAN DUJIN
Correspondent
Cavex Holland BV
2003 Rw Haarlem
P.O. Box 852
Harmen,  NL 19-21
Correspondent Contact BERNARD VAN DUJIN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/16/1998
Decision Date 05/01/1998
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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