FDA 510(k) Application Details - K102635

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K102635
Device Name Implant, Endosseous, Root-Form
Applicant CSM IMPLANT CO., LTD
325 N. PUENTE ST. UNIT B
BREA, CA 92821 US
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Contact JOYCE BANG
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 09/13/2010
Decision Date 03/22/2011
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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