Medical Device Manufacturer · TW , Chungli

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

5 submissions · 5 cleared · Since 2002

Recent clearances: ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP, ULTRA-LITE 200E LIGHT CURE UNIT, ULTRA-LITE 5 TURBO LIGHT CURE UNIT

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Dec 16, 2009

ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP

Cleared Dec 30, 2002

ULTRA-LITE 200E LIGHT CURE UNIT

Cleared Jun 12, 2002

ULTRA-LITE 5 TURBO LIGHT CURE UNIT

Cleared Jun 12, 2002

EXCELLITE TURBO LIGHT CURE UNIT

Cleared Jun 12, 2002

EXCELLITE LIGHT CURE UNIT

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Oct 03, 2026