FDA 510(k) Application Details - K093483

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K093483
Device Name Abutment, Implant, Dental, Endosseous
Applicant ASTRA TECH 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 11/09/2009
Decision Date 12/22/2009
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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