510(k) Report

Devices descending from K052648

17 later devices reach Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+1K101608Biomet 3I Patient Specific Dental Abutments-Encode AbutmentsBiomet 3i, Inc.20110—
+1K101607Biomet 3I Patient Specific Dental Abutments - Encode AbutmentsBiomet 3i, Inc.20110—
+1K102209Encode Patient Specific AbutmentBiomet 3i, Inc.201015
+2K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+2K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+2K123416Insignia with IteroOrmco Corp.20130—
+3K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+3K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+3K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+4K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+4K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+4K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+4K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+5K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—