Ultra-Lite 5 Turbo Light Cure Unit
510(k) K020874
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020874 | Date12 Jun 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EBZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6070
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ultra-Lite 5 Turbo Light Cure Unit is a dental light cure unit used by dental professionals to polymerize light-cured dental materials. It emits light energy to initiate the polymerization process. The device has a high light intensity of 1,300mW/cm2 and a wavelength of 400~500nm. It also features four modes: Ramp, Boost, Conventional/General, and Bleaching.
The Ultra-Lite 5 Turbo Light Cure Unit is supplied with thermal auto cut-off fuse for overheating protection. It is a dental device, classified under product code EBZ and regulation number 872.6070. The device has been cleared by the FDA under the 510K clearance type, with a decision code of SESE, indicating that it is substantially equivalent to a predicate device.
Other devices from Rolence Ent., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Ultra-Lite 5 Turbo Light Cure Unit used for?
The Ultra-Lite 5 Turbo Light Cure Unit is used by dental professionals to polymerize light-cured dental materials by emitting light energy that initiates the polymerization process, enabling the hardening of composites, sealants, and other light-activated dental restoratives.
What are the key technical specifications of the Ultra-Lite 5 Turbo Light Cure Unit?
The device emits light at a high intensity of 1,300mW/cm2 within a wavelength range of 400~500nm and includes four operational modes: Ramp, Boost, Conventional/General, and Bleaching, allowing clinicians to tailor curing protocols to different materials and clinical needs.
How is the Ultra-Lite 5 Turbo Light Cure Unit supplied and protected during use?
The unit is supplied with a thermal auto cut-off fuse that provides overheating protection, automatically interrupting power if internal temperatures exceed safe limits to prevent damage to the device and ensure user safety during prolonged operation.
What regulatory pathway was used for the Ultra-Lite 5 Turbo Light Cure Unit?
The Ultra-Lite 5 Turbo Light Cure Unit received FDA clearance through the traditional 510(k) pathway, with decision code SESE, indicating it was found substantially equivalent to a legally marketed predicate device under regulation number 872.6070 and product code EBZ.