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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 K060126
Device Name ABSOANCHOR MICROIMPLANT
Applicant
Dentos, Inc.
1011 N. University Ave.
Ann Arbor,  MI  48109
Applicant Contact ANNA SHAFTO
Correspondent
Dentos, Inc.
1011 N. University Ave.
Ann Arbor,  MI  48109
Correspondent Contact ANNA SHAFTO
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/18/2006
Decision Date 05/16/2006
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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