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FDA 510(k) Application Details - K242064
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K242064
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Smart Denture Conversions, LLC
1800 N Salem Street
Suite 104
Apex, NC 27523 US
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Contact
Derrik Conrad
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
07/15/2024
Decision Date
01/17/2025
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
FDA Source Information for K242064
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