Trophy
FranceFDA 510(k) applicant, unverified
- Devices
- 15
- FDA recalls
- 51 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Trophy makes
Trophy manufactures intraoral and extraoral dental X-ray imaging systems, including digital sensors like the KODAK 9000, KODAK 9000 3D, and KODAK RVG 6500 series for capturing periapical, bitewing, and panoramic dental radiographs. Their portfolio also includes dedicated extraoral imaging systems such as the KODAK 9000C and CS 9300C for cephalometric and other extraoral views, alongside specialized software for dental imaging analysis and workflow management.
All listed devices fall under Class II regulatory classification in the U.S. and are authorised via 510(k) clearance through the FDA. The company’s products are registered under the FDA’s 510(k) pathway, ensuring compliance with U.S. medical device regulations. Trophy operates as a U.S.-based manufacturer.
Catalogue
Search and filter all 15 devicesCompany details
- Other identifier
- 7695
- Address
- 4 rue F. Pelloutier, Marne La Vallee Ile-de-France
FDA recalls
FDA recall records list 5 recalls initiated by Trophy, the earliest on 2012-09-18 and the most recent on 2021-07-21. By recorded status: 1 ongoing and 4 terminated. The reasons filed fall into these groups: electrical or power, 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 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 21 Jul 2021 Z-1627-2023 Class II Ongoing Device failed to function as intended and/or failed to conform to their design specifications.
2012
- 18 Sep 2012 Z-0999-2013 Class II Terminated There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
- 18 Sep 2012 Z-1000-2013 Class II Terminated There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
- 18 Sep 2012 Z-1094-2013 Class II Terminated There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
- 18 Sep 2012 Z-1095-2013 Class II Terminated There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
Frequently asked questions
How many devices does Trophy have in the registry?
The registry currently lists 15 devices for Trophy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trophy's devices?
Among its 15 most recently registered devices, Trophy has devices listed in FDA 510(k) (15 devices).
What risk classes do Trophy's devices fall under?
Among its 15 most recently registered devices, the classes recorded for Trophy's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Trophy?
FDA recall records list 5 recalls initiated by Trophy, the most recent initiated on 2021-07-21. 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 Trophy in the registry?
The most recently registered devices listed for Trophy include CS 8100SC, CS8100SC Access, CS Imaging, CS 9600 and CS 3D Imaging.