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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 K100902
FOIA Releasable 510(k) K100902
Device Name AEDIS(TM)
Applicant
Embed Technology, LLC
161 E. Chicago Ave.
Suite 37f
Chicago,  IL  60611
Applicant Contact HOWARD STAMER
Correspondent
Embed Technology, LLC
161 E. Chicago Ave.
Suite 37f
Chicago,  IL  60611
Correspondent Contact HOWARD STAMER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/01/2010
Decision Date 06/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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