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FDA 510(k) Application Details - K082838
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K082838
Device Name
Implant, Endosseous, Root-Form
Applicant
ORTHOLUTION CO., LTD.
5536 TROWBRIDGE DRIVE
DUNWOODY, GA 30338 US
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Contact
CATHRYN 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
09/26/2008
Decision Date
11/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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