FDA 510(k) Application Details - K072595

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K072595
Device Name Implant, Endosseous, Root-Form
Applicant BASIC DENTAL IMPLANT SYSTEMS, INC.
535 ZANG STREET
SUITE 100
LAKEWOOD, CO 80228 US
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Contact RICH WEISKOPF
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 09/14/2007
Decision Date 05/09/2008
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 K072595


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