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FDA 510(k) Application Details - K052823
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K052823
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
DENTIUM, INC.
28711 JAEGER DRIVE
LAGUNA NIGUEL, CA 92677 US
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Contact
KLAAS BESSELING
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
10/04/2005
Decision Date
02/21/2006
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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