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FDA 510(k) Application Details - K210362
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K210362
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu
Daegu 42718 KR
Other 510(k) Applications for this Company
Contact
Gyu Ri Kim
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
02/08/2021
Decision Date
08/19/2021
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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