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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, Orthodontic
510(k) Number K063770
Device Name ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
Applicant
Alpha-Bio Tec , Ltd.
5335 Wisconsin Ave. NW
Suite 440
Washington,  DC  20015
Applicant Contact DANIEL J MANELLI
Correspondent
Alpha-Bio Tec , Ltd.
5335 Wisconsin Ave. NW
Suite 440
Washington,  DC  20015
Correspondent Contact DANIEL J MANELLI
Regulation Number872.3640
Classification Product Code
OAT  
Date Received12/20/2006
Decision Date 03/26/2007
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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