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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K231144
Device Name Washtrays
Applicant
Dentsply Sirona
221 West Philadelphia Street
Suite 60W
York,  PA  17401
Applicant Contact Rebecca Sporer
Correspondent
Dentsply Sirona
221 West Philadelphia Street
Suite 60W
York,  PA  17401
Correspondent Contact Rebecca Sporer
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/21/2023
Decision Date 01/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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