510(k) Report

Devices descending from K142115

2 later devices reach Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+2K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—