FDA 510(k) Application Details - K102981

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K102981
Device Name Implant, Endosseous, Root-Form
Applicant ACE SURGICAL SUPPLY COMPANY INC.
1034 PEARL ST.
BROCKTON, MA 02401 US
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Contact CAROL A HOUTS
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 10/07/2010
Decision Date 12/20/2010
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

FDA Source Information for K102981


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