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FDA 510(k) Application Details - K080598
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K080598
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
INTRA-LOCK INTERNATIONAL
6560 WEST ROGERS CIRCLE
SUITE 24
BOCA RATON, FL 33487 US
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Contact
JEFFREY SAKOFF
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
03/03/2008
Decision Date
05/21/2008
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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