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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 K253988
Device Name LiteSet Trays
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE 411 17
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE 411 17
Correspondent Contact Bernice Jim
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/12/2025
Decision Date 09/08/2026
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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