Cui Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 7
What Cui Corp. makes
Cui Corp. manufactures silicone-based prosthetic implants and prostheses for facial reconstruction, including premaxillary implants, curvilinear and articulated silicone chin prostheses, anatomical and feathered silicone malar implants, and dorsal columella prostheses. Their portfolio also includes silicone gel sheeting for soft tissue augmentation and custom facial prosthetics.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory clearance supported by 510(k) submissions. Their products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Cui Premaxillary Implant Ref K903328
510(k) 510(k)Cui Curvilinear Silicone Chin Ref K904349
510(k) 510(k)Silicone Gel Sheeting Ref K913140
510(k) 510(k)Cui Dorsal Columella Prosthesis Ref K904350
510(k) 510(k)Cui Articulated Silicone Chin Ref K903327
510(k) 510(k)Cui Anatomical Silicone Malar Ref K903329
510(k) 510(k)Cui Feathered Silicone Malar Ref K904348
510(k) 510(k)
Frequently asked questions
How many devices does Cui Corp. have in the registry?
The registry currently lists 7 devices for Cui Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cui Corp.'s devices?
Among its 7 most recently registered devices, Cui Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Cui Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Cui Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cui Corp. in the registry?
The most recently registered devices listed for Cui Corp. include CUI PREMAXILLARY IMPLANT, CUI CURVILINEAR SILICONE CHIN, SILICONE GEL SHEETING and CUI DORSAL COLUMELLA PROSTHESIS.