Q-Lux Plasma 100 Light Cure Unit
FDA 510(k) K001719 · Rolence Enterprise Co. , Ltd.
510(k) numberK001719
Submission
- Device name
- Q-Lux Plasma 100 Light Cure Unit
- Applicant
- Rolence Enterprise Co. , Ltd.
Chungli 320, TW - Received
- June 5, 2000
- Decision date
- October 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K960364 | CU-200 Light Cure UnitEBZ · Traditional | 04/15/1996SE |
| K960351 | Q-Lux Light Cure UnitEBZ · Traditional | 04/15/1996SE |
| K953628 | Prophy AngleEHK · Traditional | 09/29/1995SE |
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Questions and answers
When was Q-Lux Plasma 100 Light Cure Unit cleared by the FDA?
Q-Lux Plasma 100 Light Cure Unit (K001719) received a 510(k) decision of Substantially Equivalent on October 10, 2000, 127 days after the submission was received.
What is the product code of K001719?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.