K-Tek Orthodontic Products
Country not established
- Devices
- 1
What K-Tek Orthodontic Products makes
K-Tek Orthodontic Products manufactures orthodontic headgear, a device used to guide jaw growth and correct misalignment in pediatric and adolescent patients by applying controlled force to teeth and bones.
The company’s products are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States.
Catalogue
Orthodontic Headgear Ref K912682
510(k) 510(k)
Frequently asked questions
How many devices does K-Tek Orthodontic Products have in the registry?
The registry currently lists 1 device for K-Tek Orthodontic Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list K-Tek Orthodontic Products's devices?
Among its 1 most recently registered device, K-Tek Orthodontic Products has devices listed in FDA 510(k) (1 device).
What risk classes do K-Tek Orthodontic Products's devices fall under?
Among its 1 most recently registered device, the classes recorded for K-Tek Orthodontic Products's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from K-Tek Orthodontic Products in the registry?
The most recently registered devices listed for K-Tek Orthodontic Products include ORTHODONTIC HEADGEAR.