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FDA 510(k) Application Details - K243272
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K243272
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Zest Anchors, LLC
2875 Loker Ave E
Carlsbad, CA 92010 US
Other 510(k) Applications for this Company
Contact
David Lin
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/16/2024
Decision Date
01/14/2025
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K243272
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