510(k) Report

Devices descending from K151621

26 later devices reach BioHorizons CAD/CAM Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+1K183518Preat AbutmentsPreat Corporation2019223
+2K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+2K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+2K220823Preat AbutmentsPreat Corporation202216
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+2K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+2K193335SherlockOpen Implants, LLC20203—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+3K243824Preat AbutmentsPreat Corporation20250—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+3K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+3K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K212664SherlockOpen Implants, LLC20212—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K220482SherlockOpen Implants, LLC20221—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250967SherlockOpen Implants, LLC20250—