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FDA 510(k) Application Details - K230218
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K230218
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Dental Direkt GmbH
Industriezentrum 106-108
Spenge 32139 DE
Other 510(k) Applications for this Company
Contact
Patrick Berz
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
01/26/2023
Decision Date
04/25/2023
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
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