LED Curing Light GT-2000
FDA 510(k) K153078 · Monitex Industrial Co., Ltd.
510(k) numberK153078
Submission
- Device name
- LED Curing Light GT-2000
- Applicant
- Monitex Industrial Co., Ltd.
New Taipei City, TW - Received
- October 23, 2015
- Decision date
- June 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Dent4you AG
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|---|---|---|
| K161855 | LED Curing LightEBZ · Traditional | 11/27/2017SE |
| K152192 | LED Curing LightEBZ · Traditional | 04/07/2017SE |
| K150205 | LED Curing LightEBZ · Traditional | 08/24/2015SE |
| K133040 | LED Curing LightEBZ · Traditional | 10/07/2014SE |
| K091887 | LED Curing Light, Model GT-1500EBZ · Traditional | 09/18/2009SE |
| K080035 | LED Curing LightEBZ · Traditional | 03/03/2008SE |
| K060646 | Blue Luxcer Curing Light, Models M-830, M-835 and M-855EBZ · Traditional | 04/21/2006SE |
| K051203 | BluelexEBZ · Traditional | 05/25/2005SE |
Questions and answers
When was LED Curing Light GT-2000 cleared by the FDA?
LED Curing Light GT-2000 (K153078) received a 510(k) decision of Substantially Equivalent on June 28, 2016, 249 days after the submission was received.
What is the product code of K153078?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.