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FDA 510(k) Application Details - K111809
Device Classification Name
Implant, Endosseous, Orthodontic
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510(K) Number
K111809
Device Name
Implant, Endosseous, Orthodontic
Applicant
BIOMATERIALS KOREA INC.
5401 S. COTTONWOOD CT.
GREENWOOD VILLAGE, CO 80121 US
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Contact
Kevin Walls
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Regulation Number
872.3640
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Classification Product Code
OAT
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More FDA Info for this Product Code
Date Received
06/27/2011
Decision Date
09/26/2011
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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