Rolence Enteprise, Inc.
TaiwanFDA applicant, unverified
- Devices
- 2
What Rolence Enteprise, Inc. makes
Rolence Enterprise, Inc. manufactures intraoral cameras, including the ZOOMCAM LD-10 with accessories, and ultrasonic scalers like the ELEGANCE MS-10 (25K) for dental procedures. These devices support imaging and cleaning in oral healthcare settings.
The company’s portfolio includes Class I and Class II devices, with products listed under the FDA’s 510(k) pathway. Rolence Enterprise, Inc. is based in the United States.
Catalogue
Zoomcam Ld-10 Intraoral Camera And Accessories Ref K043325
Regimes: 510(k) Registry: 510(k)Ultrasonic Scaler Elegance Ms-10 (25K) Ref K040396
Regimes: CE MDD 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rolence Enteprise, Inc. have in the registry?
The registry currently lists 2 devices for Rolence Enteprise, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rolence Enteprise, Inc.'s devices?
Among its 2 most recently registered devices, Rolence Enteprise, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Rolence Enteprise, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Rolence Enteprise, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rolence Enteprise, Inc. in the registry?
The most recently registered devices listed for Rolence Enteprise, Inc. include ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES and ULTRASONIC SCALER ELEGANCE MS-10 (25K).