FDA 510(k) Application Details - K231144

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K231144
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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	880.6850   More FDA Info for this Regulation Number
Classification Product Code	KCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2023
Decision Date	01/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review