KaVo Dental Technologies, LLC
United Statesfrom the FDA registration address FDA establishment FEI 1017522
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 20 ongoing since 2021 (1 open in total)
Catalogue
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) Ref K172918
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1017522
- Address
- 11727 FRUEHAUF DR, CHARLOTTE, NC, 28273
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 29 Apr 2019 Z-1387-2019 Class II Terminated The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
Full distribution text
- 29 Apr 2019 Z-1387-2019 Class II Terminated The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
2018
- 31 Dec 2018 Z-1101-2019 Class II Open since 2018 ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
Frequently asked questions
How many devices does KaVo Dental Technologies, LLC have in the registry?
The registry currently lists 1 device for KaVo Dental Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list KaVo Dental Technologies, LLC's devices?
Among its 1 most recently registered device, KaVo Dental Technologies, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do KaVo Dental Technologies, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for KaVo Dental Technologies, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for KaVo Dental Technologies, LLC?
FDA recall records list 2 recalls initiated by KaVo Dental Technologies, LLC, the most recent initiated on 29 Apr 2019. 1 of them is recorded as ongoing. 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 KaVo Dental Technologies, LLC in the registry?
The most recently registered devices listed for KaVo Dental Technologies, LLC include DEXIS Titanium, KaVo IXS HD (Size 1, Size 2).