FDA 510(k) Application Details - K060126

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K060126
Device Name Implant, Endosseous, Root-Form
Applicant DENTOS INC.
1011 N. UNIVERSITY AVENUE
ANN ARBOR, MI 48109 US
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Contact ANNA SHAFTO
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 01/18/2006
Decision Date 05/16/2006
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

FDA Source Information for K060126


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