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Nobel Biocare AB

FDA 510(k) & PMA Approved Devices — 39 products

Total Devices39
Categories7
Latest Approval2026-02-18
TypeNumberDevice NameCodeDate
510(k) K252197 Nobel Biocare S Series Implants DZE 2026-02-18 View
510(k) K243834 NobelZygoma TiUltra Implant system DZE 2025-08-25 View
510(k) K240346 NobelProcera Zirconia Implant Bridge NHA 2025-01-03 View
510(k) K233208 NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium NHA 2024-01-24 View
510(k) K231898 DTX Studio Clinic (4.0) LLZ 2023-12-08 View
510(k) K223677 Titanium Abutment Blank Nobel Biocare N1 TCC NHA 2023-04-28 View
510(k) K221921 DTX Studio Clinic 3.0 MYN 2023-03-28 View
510(k) K213562 DTX Studio Clinic 3.0 LLZ 2022-03-25 View
510(k) K202452 NobelProcera Zirconia Implant Bridge NHA 2020-12-03 View
510(k) K203156 DTX Studio Clinic LLZ 2020-11-20 View
510(k) K202344 TiUltra Implants and Xeal Abutments DZE 2020-11-16 View
510(k) K200810 IPS CaseDesigner LLZ 2020-10-08 View
510(k) K191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate KCT 2019-08-29 View
510(k) K181932 DTX Studio design PNP 2019-03-01 View
510(k) K173418 NobelParallel Conical Connection DZE 2019-02-21 View
510(k) K181869 On1 Universal Abutment NHA 2018-12-12 View
510(k) K183069 NobelZygoma 0° DZE 2018-12-04 View
510(k) K180899 Universal Base Abutment NHA 2018-10-31 View
510(k) K181075 PureSet Tray KCT 2018-09-27 View
510(k) K163600 Kit Boxes and Kit Plates KCT 2018-01-22 View
510(k) K172224 DTX Studio diagnose LLZ 2018-01-11 View
510(k) K172854 NobelPerfect Abutments NHA 2017-12-14 View
510(k) K171466 NobelDesign, DTX Studio Design NHA 2017-11-29 View
510(k) K171142 Healing Cap Multi-Unit Titanium NHA 2017-10-26 View
510(k) K172352 TREFOIL System DZE 2017-10-20 View
510(k) K170135 TREFOIL System DZE 2017-05-11 View
510(k) K161416 Multi-unit Abutment Plus NHA 2017-03-16 View
510(k) K161598 NobelZygoma 0° DZE 2017-03-14 View
510(k) K161655 On1 Concept NHA 2017-02-28 View
510(k) K163122 NobelClinician, DTX Studio implant LLZ 2017-01-31 View
510(k) K162043 NobelProcera HT ML FCZ Bridge ELL 2016-11-22 View
510(k) K161435 Temporary Snap Abutment NHA 2016-11-22 View
510(k) K161634 IPS CaseDesigner LLZ 2016-11-10 View
510(k) K160158 NobelProcera HT ML FCZ Implant Bridge and Framework NHA 2016-07-25 View
510(k) K153534 NobelProcera HT ML Full Contour Zirconia Crown ELL 2016-06-06 View
510(k) K160119 NobelSpeedy Groovy DZE 2016-06-02 View
510(k) K153036 NobelDesign Software NHA 2016-06-02 View
510(k) K152836 TREFOIL System DZE 2016-04-11 View
510(k) K152093 NobelZygoma 45° DZE 2016-03-16 View
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