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FDA 510(k) Application Details - K240888
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K240888
Device Name
Cement, Dental
Applicant
Dentsply Sirona
221 West Philadelphia Street
Suite 60W
York, PA 17401 US
Other 510(k) Applications for this Company
Contact
Rebecca Sporer
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
04/01/2024
Decision Date
04/02/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
Y
Expedited Review
FDA Source Information for K240888
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