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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 K113650
Device Name ORTHOFIX SCREW
Applicant
Bonafix Surgical and Dental Implants, LLC
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Applicant Contact JUAN TEZAK
Correspondent
Bonafix Surgical and Dental Implants, LLC
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Correspondent Contact JUAN TEZAK
Regulation Number872.3640
Classification Product Code
OAT  
Date Received12/12/2011
Decision Date 10/03/2012
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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