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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K093113
Device Name ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT
Applicant
INSTITUT STRAUMANN AG
LOCHHAMER SCHLAG 6
GRAEFELFING, BAVARIA,  DE 82166
Applicant Contact ANDREAS PETERMANN
Correspondent
INSTITUT STRAUMANN AG
LOCHHAMER SCHLAG 6
GRAEFELFING, BAVARIA,  DE 82166
Correspondent Contact ANDREAS PETERMANN
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
NOF  
Date Received10/01/2009
Decision Date 12/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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