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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 K251300
Device Name Plastic Surgical Kits
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Applicant Contact Laura Sobrin
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Correspondent Contact Laura Sobrin
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/28/2025
Decision Date 07/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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