Nobel Biocare Services AG
Country not established FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Nobel Biocare Services AG makes
The company manufactures dental implants and related components, including titanium-based implant systems (e.g., TiUnite, TiUltra), custom-milled zirconia bases for prosthetic restorations, and abutments designed for implant-supported crowns and bridges. Products also include surgical trays for implant placement and pre-fabricated implant systems for immediate or delayed loading in oral rehabilitation.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States and its products are listed in the FDA’s 510(k) database.
Catalogue
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray Ref K212932
Regimes: 510(k) Registry: 510(k)N1 TiUltra TCC Implant System Ref K211109
Regimes: 510(k) Registry: 510(k)NobelProcera Zirconia N1 Base Ref K220048
Regimes: 510(k) Registry: 510(k)Esthetic Abutments Nobel Biocare N1 Ref K220339
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Nobel Biocare Services AG, initiated on 2020-07-20. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 20 Jul 2020 Z-2828-2020 Class II Terminated Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
Full distribution text
- 20 Jul 2020 Z-2828-2020 Class II Terminated Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
FDA establishments
- Nobel Biocare Services AG Kloten Zurich · CH FEI 3008693672
Frequently asked questions
How many devices does Nobel Biocare Services AG have in the registry?
The registry currently lists 4 devices for Nobel Biocare Services AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nobel Biocare Services AG's devices?
Among its 4 most recently registered devices, Nobel Biocare Services AG has devices listed in FDA 510(k) (4 devices).
What risk classes do Nobel Biocare Services AG's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Nobel Biocare Services AG's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Nobel Biocare Services AG?
FDA recall records list 1 recall initiated by Nobel Biocare Services AG, the most recent initiated on 20 Jul 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Nobel Biocare Services AG in the registry?
The most recently registered devices listed for Nobel Biocare Services AG include Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray, N1 TiUltra TCC Implant System, NobelProcera Zirconia N1 Base and Esthetic Abutments Nobel Biocare N1.
Which FDA establishments are linked to Nobel Biocare Services AG?
1 FDA establishment is linked to Nobel Biocare Services AG in the registry; they are listed on the company page.