FDA 510(k) Application Details - K122052

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K122052
Device Name Implant, Endosseous, Root-Form
Applicant BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
118 W. PRIVE CR.
DELRAY BEACH, FL 33445 US
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Contact JUAN TEZAK
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 07/12/2012
Decision Date 11/28/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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