FDA 510(k) Application Details - K251786

Device Classification Name Bone Grafting Material, Animal Source

  More FDA Info for this Device
510(K) Number K251786
Device Name Bone Grafting Material, Animal Source
Applicant Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen 6110 CH
Other 510(k) Applications for this Company
Contact Erik Wirth
Other 510(k) Applications for this Contact
Regulation Number 872.3930

  More FDA Info for this Regulation Number
Classification Product Code NPM
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/11/2025
Decision Date 07/11/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K251786


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact