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FDA 510(k) Application Details - K083141
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K083141
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
SIMPACT LLC
300 INTERPACE PARKWAY
SUITE 410
PARSIPPANY, NJ 07054 US
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Contact
MARK SCHENK
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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
10/23/2008
Decision Date
11/07/2008
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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