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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
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