510(k) Report

Devices descending from K003271

612 later devices reach Modification to Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+10K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+10K241032BellaTek BarsBiomet 3i, LLC20241—
+10K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+10K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+10K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+10K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+11K260940BellaTek BarsZimVie US Corp, LLC20260—
+11K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—