510(k) Report

Devices descending from K190299

13 later devices reach Elos Accurate® Customized Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+1K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+1K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+1K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+2K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+2K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+2K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+2K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+3K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+3K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+3K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+3K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+4K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—