Nobel Biocare USA, LLC
United Statesfrom the FDA registration address FDA establishment FEI 1000125598
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 68
What Nobel Biocare USA, LLC makes
The company manufactures dental implants and abutments, including tapered conical and hexagonal implant systems, zirconia-based dental ceramics, and custom abutments for multi-unit restorations. Products also include non-engaging and engaging implant analogs for surgical planning, as well as zygoma implants and titanium-based abutments for complex cases.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Nobelprocera Overdenture Bar Ref K132749
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Nobelrondo Dental Ceramic - Zirconia Ref K043312
Regimes: 510(k) Registry: 510(k)Nobelreplace Tapered Conical Connection Ref K062566
Regimes: 510(k) Registry: 510(k)Zygoma 17 Abutment Multi-Unit Rp 2mm, Model 29314; Zygoma 17 Abutment Multi-Unit Rp 3mm, Model 29315 Ref K052885
Regimes: CE MDR 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Nobelreplace Hexagonal Implant Ref K073142
Regimes: 510(k) Registry: 510(k)Zygoma Tiunite Ref K050641
Regimes: 510(k) Registry: 510(k)Nobelprocera Zi Abutment Thommen Platforms Ref K110171
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000125598
- Address
- 22715 Savi Ranch Parkway, YORBA LINDA, CA, 92887
FDA recalls
FDA recall records list 68 recalls initiated by NOBEL BIOCARE USA, LLC, the earliest on 2003-01-27 and the most recent on 2021-12-17. By recorded status: 68 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. 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 1
- 2019 33
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 17 Dec 2021 Z-0658-2022 Class II Terminated Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
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- 17 Dec 2021 Z-0658-2022 Class II Terminated Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
2019
- 28 Aug 2019 Z-1851-2020 Class II Terminated The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
- 9 Aug 2019 Z-1852-2020 Class II Terminated Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
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- 9 Aug 2019 Z-1853-2020 Class II Terminated Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
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- 9 Aug 2019 Z-1854-2020 Class II Terminated Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
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- 9 Aug 2019 Z-1855-2020 Class II Terminated Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
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- 9 Aug 2019 Z-1856-2020 Class II Terminated Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
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- 9 Aug 2019 Z-1857-2020 Class II Terminated Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
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- 19 Jul 2019 Z-2207-2020 Class II Terminated The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
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- 28 May 2019 Z-2250-2020 Class II Terminated Packaged dental implant healing abutments were found to contain the wrong size device.
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Show the 25 most recent of 68 recalls
2019
- 14 Mar 2019 Z-1302-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1303-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1304-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1305-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1306-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1307-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1308-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1309-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1310-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1311-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1312-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1313-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1314-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1315-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1316-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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- 14 Mar 2019 Z-1302-2020 Class II Terminated Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Frequently asked questions
How many devices does NOBEL BIOCARE USA, LLC have in the registry?
The registry currently lists 9 devices for NOBEL BIOCARE USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list NOBEL BIOCARE USA, LLC's devices?
Among its 9 most recently registered devices, NOBEL BIOCARE USA, LLC has devices listed in FDA 510(k) (9 devices).
What risk classes do NOBEL BIOCARE USA, LLC's devices fall under?
Among its 9 most recently registered devices, the classes recorded for NOBEL BIOCARE USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for NOBEL BIOCARE USA, LLC?
FDA recall records list 68 recalls initiated by NOBEL BIOCARE USA, LLC, the most recent initiated on 17 Dec 2021. 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 USA, LLC in the registry?
The most recently registered devices listed for NOBEL BIOCARE USA, LLC include NOBELPROCERA OVERDENTURE BAR, GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP, NOBELRONDO DENTAL CERAMIC - ZIRCONIA and NOBELREPLACE TAPERED CONICAL CONNECTION.