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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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



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