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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 K231219
Device Name NobelZygoma PureSet™ Tray
Applicant
Nobel Biocare Services AG
Balz Zimmermann-Str. 7
Kloten,  CH 8302
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare Services AG
Balz Zimmermann-Str. 7
Kloten,  CH 8302
Correspondent Contact Bernice Jim
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/28/2023
Decision Date 06/27/2023
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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