Medical Device Manufacturer · TW , Chungi

Rolence Enteprise, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2004

Recent clearances: ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES, ULTRASONIC SCALER ELEGANCE MS-10 (25K)

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rolence Enteprise, Inc. Dental ✕

2 devices

1-2 of 2

Cleared Feb 11, 2005

ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES

Cleared Apr 22, 2004

ULTRASONIC SCALER ELEGANCE MS-10 (25K)

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 25, 2026