Medical Device Manufacturer · SE , Goteborg

Nobel Biocare AB - FDA 510(k) Cleared Devices

93 submissions · 93 cleared · Since 2002

Recent clearances: Universal Base ASC Engaging, Nobel Biocare S Series Implants, NobelZygoma TiUltra Implant system

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93

Total

93

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nobel Biocare AB Dental ✕

80 devices

1-12 of 80

Cleared Aug 06, 2026

Universal Base ASC Engaging

Cleared Feb 18, 2026

Nobel Biocare S Series Implants

Cleared Aug 25, 2025

NobelZygoma TiUltra Implant system

Cleared Jan 03, 2025

NobelProcera Zirconia Implant Bridge

Cleared Jan 24, 2024

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

Cleared Apr 28, 2023

Titanium Abutment Blank Nobel Biocare N1 TCC

Cleared Dec 03, 2020

NobelProcera Zirconia Implant Bridge

Cleared Nov 16, 2020

TiUltra Implants and Xeal Abutments

Cleared Mar 01, 2019

DTX Studio design

Cleared Feb 21, 2019

NobelParallel Conical Connection

Cleared Dec 12, 2018

On1 Universal Abutment

Cleared Dec 04, 2018

NobelZygoma 0°

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