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FDA 510(k) Application Details - K200827
Device Classification Name
Abutment, Implant, Dental, Endosseous
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510(K) Number
K200827
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Ivory Super Holdco, Incp.
2875 Locker Ave East
Carlsbad, CA 92010 US
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Contact
Marysa Loustalot
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
03/30/2020
Decision Date
09/02/2020
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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