Flash-Lite LED Dental Curing Light
FDA 510(k) K022184 · Discus Dental, Inc.
510(k) numberK022184
Submission
- Device name
- Flash-Lite LED Dental Curing Light
- Applicant
- Discus Dental, Inc.
Culver City, CA, US - Received
- July 3, 2002
- Decision date
- August 20, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K253131 | Curing Light (M-Cure 6)EBZ · Traditional | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 06/18/2026SE |
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| K243921 | LED Curing Lights (DB686 HALO)EBZ · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 04/11/2025SE |
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| K223414 | Curing Light, Model: MaxCure 9EBZ · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 11/15/2023SE |
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| K223142 | Coltolux Comfort LED Curing LightEBZ · Traditional | Dent4you AG | 12/22/2022SE |
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Questions and answers
When was Flash-Lite LED Dental Curing Light cleared by the FDA?
Flash-Lite LED Dental Curing Light (K022184) received a 510(k) decision of Substantially Equivalent on August 20, 2002, 48 days after the submission was received.
What is the product code of K022184?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.