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FDA 510(k) Application Details - K213609
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K213609
Device Name
Cement, Dental
Applicant
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
Fetih Mahallesi Mahir Sokak No:5/201
Konya 42030 TR
Other 510(k) Applications for this Company
Contact
Hⁿsamettin Sonmez
Other 510(k) Applications for this Contact
Regulation Number
872.3275
More FDA Info for this Regulation Number
Classification Product Code
EMA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/15/2021
Decision Date
08/09/2022
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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