510(k) Report

Devices descending from K180185

3 later devices reach Bio-C Repair through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243353One-Fil PuttyMediclus Co., Ltd.20251—
+1K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+2K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—