Not currently registered with FDA under this name
Rolence Enteprise, Inc.
Chungi, Taiwan. Named as applicant on 2 dental 510(k) clearances between 2004 and 2005. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22004–2005
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Rolence Enteprise, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Feb 2005 | K043325 | ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES | EIA Operative Dental Unit |
| 22 Apr 2004 | K040396 | ULTRASONIC SCALER ELEGANCE MS-10 (25K) | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: Rolence Ent., Inc. (2), 3D Dental Designs and Development LLC (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.