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FDA 510(k) Application Details - K222044
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K222044
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Elos Medtech Pinol A/S
Engvej 33
Goerloese 3330 DK
Other 510(k) Applications for this Company
Contact
Lise Terkelsen
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
07/11/2022
Decision Date
11/30/2022
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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