Nobel Biocare

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
94
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1101-2025Class II. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel BiocaJanuary 10, 2025
Z-1565-2022Class IINobel Biocare N1 TiUltra TCC NP 3.5x13mmJuly 25, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K252197Nobel Biocare S Series ImplantsFebruary 18, 2026
K243834NobelZygoma TiUltra Implant systemAugust 25, 2025
K240346NobelProcera Zirconia Implant BridgeJanuary 3, 2025
K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumJanuary 24, 2024
K231898DTX Studio Clinic (4.0)December 8, 2023
K223677Titanium Abutment Blank Nobel Biocare N1 TCCApril 28, 2023
K221921DTX Studio Clinic 3.0March 28, 2023
K213562DTX Studio Clinic 3.0March 25, 2022
K212125Nobel Biocare Dental Implant Systems Portfolio - MR ConditionalSeptember 24, 2021
K202452NobelProcera Zirconia Implant BridgeDecember 3, 2020
K203156DTX Studio ClinicNovember 20, 2020
K202344TiUltra Implants and Xeal AbutmentsNovember 16, 2020
K200810IPS CaseDesignerOctober 8, 2020
K200040Universal Base Conical Connection (CC)March 30, 2020
K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PAugust 29, 2019
K181932DTX Studio designMarch 1, 2019
K173418NobelParallel Conical ConnectionFebruary 21, 2019
K181869On1 Universal AbutmentDecember 12, 2018
K183069NobelZygoma 0°December 4, 2018
K180899Universal Base AbutmentOctober 31, 2018