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FDA 510(k) Application Details - K211871
Device Classification Name
Abutment, Implant, Dental, Endosseous
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510(K) Number
K211871
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Faico Medical LLC
2424 North Federal Highway, Suite 103
Boca Raton, FL 33428 US
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Contact
Hernan Dario Fernandez
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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
06/17/2021
Decision Date
11/18/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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