FDA 510(k) Application Details - K955619

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K955619
Device Name Implant, Endosseous, Root-Form
Applicant CALCITEK, INC.
2320 FARADAY AVE.
CARLSBAD, CA 92008-7216 US
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Contact DONNA K HOWARD
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 12/11/1995
Decision Date 03/08/1996
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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