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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 K063495
Device Name C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
Applicant
BIOMATERIALS KOREA INC.
13 RED FOX LANE
LITTLETON,  CO  80127
Applicant Contact KEVIN WALLS, RAC
Correspondent
BIOMATERIALS KOREA INC.
13 RED FOX LANE
LITTLETON,  CO  80127
Correspondent Contact KEVIN WALLS, RAC
Regulation Number872.3640
Classification Product Code
OAT  
Date Received11/20/2006
Decision Date 07/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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