FDA 510(k) Application Details - K974106

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K974106
Device Name Implant, Endosseous, Root-Form
Applicant BIO SCIENCE TECHNOLOGIES, INC.
8910 UNIVERSITY CENTER LANE,
SUITE 265
SAN DIEGO, CA 92122-1085 US
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Contact ALAN DONALD
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 10/31/1997
Decision Date 06/01/1998
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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