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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K050478
Device Name MEDICON IMF-ORION SCREWS
Applicant
Medicon EG
Gaensaecker 15
Tuttlingen,  DE D-78532
Applicant Contact JOACHIM SCHMID
Correspondent
Medicon EG
Gaensaecker 15
Tuttlingen,  DE D-78532
Correspondent Contact JOACHIM SCHMID
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/24/2005
Decision Date 06/15/2005
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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