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Nobel Biocare AB

FDA 510(k) & PMA Approved Devices — 40 products

Total Devices40
Categories7
Latest FDA decision2026-08-06
TypeNumberDevice NameCodeDateActions
510(k) K253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNHA2026-08-06 View
510(k) K252197 Nobel Biocare S Series ImplantsDZE2026-02-18 View
510(k) K243834 NobelZygoma TiUltra Implant systemDZE2025-08-25 View
510(k) K240346 NobelProcera Zirconia Implant BridgeNHA2025-01-03 View
510(k) K233208 NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNHA2024-01-24 View
510(k) K231898 DTX Studio Clinic (4.0)LLZ2023-12-08 View
510(k) K223677 Titanium Abutment Blank Nobel Biocare N1 TCCNHA2023-04-28 View
510(k) K221921 DTX Studio Clinic 3.0MYN2023-03-28 View
510(k) K213562 DTX Studio Clinic 3.0LLZ2022-03-25 View
510(k) K202452 NobelProcera Zirconia Implant BridgeNHA2020-12-03 View
510(k) K203156 DTX Studio ClinicLLZ2020-11-20 View
510(k) K202344 TiUltra Implants and Xeal AbutmentsDZE2020-11-16 View
510(k) K200810 IPS CaseDesignerLLZ2020-10-08 View
510(k) K191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet PlateKCT2019-08-29 View
510(k) K181932 DTX Studio designPNP2019-03-01 View
510(k) K173418 NobelParallel Conical ConnectionDZE2019-02-21 View
510(k) K181869 On1 Universal AbutmentNHA2018-12-12 View
510(k) K183069 NobelZygoma 0°DZE2018-12-04 View
510(k) K180899 Universal Base AbutmentNHA2018-10-31 View
510(k) K181075 PureSet TrayKCT2018-09-27 View

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