Sylphar N.V.
Country not established
- Devices
- 2
What Sylphar N.V. makes
Sylphar N.V. manufactures dental products designed to relieve tooth sensitivity, including topical strips and treatments for sensitive teeth. These items are intended for at-home use to provide temporary relief from discomfort caused by temperature or tactile stimuli.
The company’s portfolio is regulated under FDA’s Class II device classification, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Remesense For Sensitive Teeth Ref K122708
Regimes: 510(k) Registry: 510(k)Sylphar Remesense Sensitivity Relief Strips Ref K132426
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sylphar N.V. have in the registry?
The registry currently lists 2 devices for Sylphar N.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sylphar N.V.'s devices?
Among its 2 most recently registered devices, Sylphar N.V. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sylphar N.V.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sylphar N.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sylphar N.V. in the registry?
The most recently registered devices listed for Sylphar N.V. include REMESENSE FOR SENSITIVE TEETH and SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS.