Cefla Dental Group
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Cefla Dental Group makes
Cefla Dental Group manufactures digital X-ray sensors, including the WDS X-POD and ZEN-X, designed for intraoral imaging in dental settings. They also produce the MYRAY Hyperion, a portable dental X-ray system for capturing high-resolution images.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Wds X-Pod And Zen-X Digital X-Ray Sensors Ref K100960
Regimes: 510(k) Registry: 510(k)Myray Hyperion Ref K101661
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Cefla Dental Group, initiated on 2012-08-10. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 10 Aug 2012 Z-1217-2013 Class II Terminated The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at ma
Frequently asked questions
How many devices does Cefla Dental Group have in the registry?
The registry currently lists 2 devices for Cefla Dental Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cefla Dental Group's devices?
Among its 2 most recently registered devices, Cefla Dental Group has devices listed in FDA 510(k) (2 devices).
What risk classes do Cefla Dental Group's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cefla Dental Group's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cefla Dental Group?
FDA recall records list 1 recall initiated by Cefla Dental Group, the most recent initiated on 10 Aug 2012. 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 Cefla Dental Group in the registry?
The most recently registered devices listed for Cefla Dental Group include WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS and MYRAY HYPERION.