510(k) Report

Devices descending from K202026

11 later devices reach Blue Sky Bio CAD-CAM Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+1K212108Dynamic TiBaseTalladium España, SL20219—
+2K231566ICX-Implant SystemMedentis Medical GmbH20240—
+2K221673Bonafix TiBaseZentek Medical, LLC20231—
+2K221966Dynamic TiBaseTalladium Espana, SL20225—
+3K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+3K231559Multi-Unit DAS SystemTalladium España, SL20231—
+3K232151Dynamic TiBaseTalladium España, SL20232—
+4K243732Multi-Unit DAS SystemTalladium España, SL20260—
+4K243530Dynamic TiBaseTalladium España, SL20250—
+4K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—