Dentalez Group, Stardental Division
Country not established
- Devices
- 2
- FDA recalls
- 32 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Dentalez Group, Stardental Division makes
Dentalez Group’s Stardental Division manufactures dental handpieces, including high-speed variants like the 430 SWL 45 and 430 SW 45, as well as programmable electric torque systems such as the Nutorque. These tools are designed for precision dental procedures, including drilling and torque-controlled applications.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. The portfolio is regulated under US FDA standards, and the manufacturer is based in the United States.
Catalogue
430 Swl 45 And 430 Sw 45 High-Speed Handpieces Ref K130455
Regimes: 510(k) Registry: 510(k)Nutorque Programmable Electric System Ref K083252
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Dentalez Group, Stardental Division, the earliest on 2014-06-13 and the most recent on 2024-05-30. By recorded status: 2 ongoing and 1 terminated. The reasons filed fall into these groups: 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 0
- 2022 0
- 2023 0
- 2024 2
- 2025 0
- 2026 0
2024
- 30 May 2024 Z-2177-2024 Class II Ongoing Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
- 30 May 2024 Z-2178-2024 Class II Ongoing Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
2014
- 13 Jun 2014 Z-2078-2014 Class II Terminated The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
Frequently asked questions
How many devices does Dentalez Group, Stardental Division have in the registry?
The registry currently lists 2 devices for Dentalez Group, Stardental Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dentalez Group, Stardental Division's devices?
Among its 2 most recently registered devices, Dentalez Group, Stardental Division has devices listed in FDA 510(k) (2 devices).
What risk classes do Dentalez Group, Stardental Division's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dentalez Group, Stardental Division's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Dentalez Group, Stardental Division?
FDA recall records list 3 recalls initiated by Dentalez Group, Stardental Division, the most recent initiated on 30 May 2024. 2 of them are 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 Dentalez Group, Stardental Division in the registry?
The most recently registered devices listed for Dentalez Group, Stardental Division include 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES and NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM.