FDA 510(k) Application Details - K062051

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K062051
Device Name Implant, Endosseous, Root-Form
Applicant OSSTEM IMPLANT CO.,LTD
5536 TROWBRIDGE DRIVE
DUNWOODY, GA 30338 US
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Contact CATHRYN N CAMBRIA
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 07/19/2006
Decision Date 11/01/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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