Rolence Ent., Inc.
TaiwanFDA applicant, unverified FDA
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
Catalogue
Excellite Light Cure Unit Ref K020884
Regimes: 510(k) Registry: 510(k)Ultra-Lite 200E Light Cure Unit Ref K023545
Regimes: 510(k) Registry: 510(k)Rolence Dental High Speed Handpiece, Rhp Ref K093084
Regimes: 510(k) Registry: 510(k)Excellite Turbo Light Cure Unit Ref K020877
Regimes: 510(k) Registry: 510(k)Ultra-Lite 5 Turbo Light Cure Unit Ref K020874
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Rolence Ent. Inc. CHUNGLI Taoyuan · TW FEI 3002772487
Frequently asked questions
How many devices does Rolence Ent., Inc. have in the registry?
The registry currently lists 5 devices for Rolence Ent., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rolence Ent., Inc.'s devices?
Among its 5 most recently registered devices, Rolence Ent., Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Rolence Ent., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Rolence Ent., 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 Ent., Inc. in the registry?
The most recently registered devices listed for Rolence Ent., Inc. include EXCELLITE LIGHT CURE UNIT, ULTRA-LITE 200E LIGHT CURE UNIT, ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP and EXCELLITE TURBO LIGHT CURE UNIT.
Which FDA establishments are linked to Rolence Ent., Inc.?
1 FDA establishment is linked to Rolence Ent., Inc. in the registry; they are listed on the company page.