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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 K061804
Device Name ZERION ALPHA, ; ZERION BETA
Applicant
Etkon International GmbH
Lochhamer Schlag 6
Graefelfing, Bavaria,  DE 82166
Applicant Contact MATTHIAS ZITZMANN
Correspondent
Etkon International GmbH
Lochhamer Schlag 6
Graefelfing, Bavaria,  DE 82166
Correspondent Contact MATTHIAS ZITZMANN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/27/2006
Decision Date 10/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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