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FDA 510(k) Application Details - K061397
Device Classification Name
Implant, Endosseous, Orthodontic
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510(K) Number
K061397
Device Name
Implant, Endosseous, Orthodontic
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
OAT
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More FDA Info for this Product Code
Date Received
05/19/2006
Decision Date
08/16/2006
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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