Medical Device Manufacturer · SE , Goteborg

Nobel Biocare AB

92 submissions · 92 cleared · Since 2002
92
Total
92
Cleared
0
Denied

Nobel Biocare AB — FDA 510(k) Submissions

Nobel Biocare AB has submitted 92 FDA 510(k) premarket notifications since 2002, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Abutment, Implant, Dental, Endosseous, Implant, Endosseous, Root-form, System, Image Processing, Radiological, Teeth, Porcelain, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories . Use the specialty filter in the sidebar to narrow results.

92 devices
1–25 of 92
Nobel Biocare S Series Implants
K252197 · DZE Implant, Endosseous,... · Dental
Feb 2026 219d
NobelZygoma TiUltra Implant system
K243834 · DZE Implant, Endosseous,... · Dental
Aug 2025 255d
NobelProcera Zirconia Implant Bridge
K240346 · NHA Abutment, Implant,... · Dental
Jan 2025 333d
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
K233208 · NHA Abutment, Implant,... · Dental
Jan 2024 118d
DTX Studio Clinic (4.0)
K231898 · LLZ System, Image Processing,... · Radiology
Dec 2023 163d
Titanium Abutment Blank Nobel Biocare N1 TCC
K223677 · NHA Abutment, Implant,... · Dental
Apr 2023 141d
DTX Studio Clinic 3.0
K221921 · MYN Analyzer, Medical Image · Radiology
Mar 2023 270d
DTX Studio Clinic 3.0
K213562 · LLZ System, Image Processing,... · Radiology
Mar 2022 136d
NobelProcera Zirconia Implant Bridge
K202452 · NHA Abutment, Implant,... · Dental
Dec 2020 98d
DTX Studio Clinic
K203156 · LLZ System, Image Processing,... · Radiology
Nov 2020 29d
TiUltra Implants and Xeal Abutments
K202344 · DZE Implant, Endosseous,... · Dental
Nov 2020 90d
IPS CaseDesigner
K200810 · LLZ System, Image Processing,... · Radiology
Oct 2020 195d
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
K191475 · KCT Sterilization Wrap... · General Hospital
Aug 2019 86d
DTX Studio design
K181932 · PNP Dental Abutment Design... · Dental
Mar 2019 225d
NobelParallel Conical Connection
K173418 · DZE Implant, Endosseous,... · Dental
Feb 2019 477d
On1 Universal Abutment
K181869 · NHA Abutment, Implant,... · Dental
Dec 2018 153d
NobelZygoma 0?
K183069 · DZE Implant, Endosseous,... · Dental
Dec 2018 29d
Universal Base Abutment
K180899 · NHA Abutment, Implant,... · Dental
Oct 2018 208d
PureSet Tray
K181075 · KCT Sterilization Wrap... · General Hospital
Sep 2018 156d
Kit Boxes and Kit Plates
K163600 · KCT Sterilization Wrap... · General Hospital
Jan 2018 397d
DTX Studio diagnose
K172224 · LLZ System, Image Processing,... · Radiology
Jan 2018 170d
NobelPerfect Abutments
K172854 · NHA Abutment, Implant,... · Dental
Dec 2017 85d
NobelDesign, DTX Studio Design
K171466 · NHA Abutment, Implant,... · Dental
Nov 2017 195d
Healing Cap Multi-Unit Titanium
K171142 · NHA Abutment, Implant,... · Dental
Oct 2017 191d
TREFOIL System
K172352 · DZE Implant, Endosseous,... · Dental
Oct 2017 78d

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