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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 K111809
Device Name SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
Applicant
Biomaterials Korea, Inc.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Applicant Contact Kevin Walls
Correspondent
Biomaterials Korea, Inc.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number872.3640
Classification Product Code
OAT  
Date Received06/27/2011
Decision Date 09/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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