Rolence Enterprise Co., Ltd.
TaiwanFDA applicant, unverified
Part of Rolence Enterprise Inc.
- Devices
- 20
What Rolence Enterprise Co., Ltd. makes
Rolence Enterprise Co., Ltd. manufactures dental light cure units, including models such as the Q-LUX PLASMA 100, CU-200, and Q-LITE 75, designed for curing composite resins and other dental materials. Additional variants include the Q-LUXPRO V/Q-LUXPRO II, CU-80, and CUTE-LITE I, as well as the PROPHY ANGLE, a dental prophylaxis tool. The portfolio also includes the CU-100RLC, CU-100A, and a generic 100 Light Cure Unit.
The company’s devices are regulated under FDA 510(k) clearance, with some models classified as Class I and others as Class II. These products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Rolence Enterprise Co., Ltd. have in the registry?
The registry currently lists 20 devices for Rolence Enterprise Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rolence Enterprise Co., Ltd.'s devices?
Among its 20 most recently registered devices, Rolence Enterprise Co., Ltd. has devices listed in FDA 510(k) (12 devices) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Rolence Enterprise Co., Ltd.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Rolence Enterprise Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rolence Enterprise Co., Ltd. in the registry?
The most recently registered devices listed for Rolence Enterprise Co., Ltd. include ELiTEDENT Q-4W, Rolence CU-80, Ultra-Lite 5 Turbo and Rolence CU-100A.