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FDA 510(k) Application Details - K070228
Device Classification Name
Abutment, Implant, Dental, Endosseous
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510(K) Number
K070228
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
DENTIUM CO., LTD.
5536 TROWBRIDGE DR
ATLANTA, GA 30338 US
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Contact
CATHRYN N CAMBRIA
Other 510(k) Applications for this Contact
Regulation Number
872.3630
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Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
01/24/2007
Decision Date
11/20/2007
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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