FDA 510(k) Application Details - K092594

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K092594
Device Name Implant, Endosseous, Root-Form
Applicant ACE SURGICAL SUPPLY CO., INC.
1034 PEARL ST.
BROCKTON, MA 02301 US
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Contact J.EDWARD CARCHIDI
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 08/24/2009
Decision Date 09/16/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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