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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, root-form
510(k) Number K122052
Device Name MINIFIX BALL MINIFIX ONE
Original Applicant
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
118 w. prive cr.
delray beach,  FL  33445
Original Contact juan tezak
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/12/2012
Decision Date 11/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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