FDA 510(k) Application Details - K053450

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K053450
Device Name Abutment, Implant, Dental, Endosseous
Applicant ATLANTIS COMPONENTS, INC.
8944 TAMAROA TERRACE
SKOKIE, IL 60076 US
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Contact BETSY A BROWN
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 12/12/2005
Decision Date 03/03/2006
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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