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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Animal Source
510(k) Number K260096
Device Name Wishbone HAE
Applicant
Wishbone SA
Rue De L'Expansion 1
Flémalle,  BE 4400
Applicant Contact Caroline Trus
Correspondent
Wishbone SA
Rue De L'Expansion 1
Flémalle,  BE 4400
Correspondent Contact Emilie Dory
Regulation Number872.3930
Classification Product Code
NPM  
Date Received01/13/2026
Decision Date 10/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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