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FDA 510(k) Application Details - K992582
Device Classification Name
Point, Silver, Endodontic
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510(K) Number
K992582
Device Name
Point, Silver, Endodontic
Applicant
PACIFIC IMPLANT, INC.
2000 M. ST. N.W. 7TH FLOOR
WASHINGTON, DC 20036 US
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Contact
DANIEL J MANELLI
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Regulation Number
872.3840
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Classification Product Code
EKL
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More FDA Info for this Product Code
Date Received
08/02/1999
Decision Date
10/21/1999
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
FDA Source Information for K992582
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