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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Powder, Porcelain
510(k) Number K033221
Device Name KAVO EVEREST ZH-BLANK
Applicant
Kavo America Corporation
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Kavo America Corporation
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/03/2003
Decision Date 10/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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