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FDA 510(k) Application Details - K251084
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K251084
Device Name
Powder, Porcelain
Applicant
estetic ceram ag
Landstrasse 109
Triesen 9495 LI
Other 510(k) Applications for this Company
Contact
Micheal Reise
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2025
Decision Date
06/05/2025
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K251084
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