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FDA 510(k) Application Details - K060501
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K060501
Device Name
Implant, Endosseous, Root-Form
Applicant
DENTIUM 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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More FDA Info for this Product Code
Date Received
02/24/2006
Decision Date
06/16/2006
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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