LED Curing Light, Model GT-1500
FDA 510(k) K091887 · Monitex Industrial Co., Ltd.
510(k) numberK091887
Submission
- Device name
- LED Curing Light, Model GT-1500
- Applicant
- Monitex Industrial Co., Ltd.
San-Chung City, TW - Received
- June 24, 2009
- Decision date
- September 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was LED Curing Light, Model GT-1500 cleared by the FDA?
LED Curing Light, Model GT-1500 (K091887) received a 510(k) decision of Substantially Equivalent on September 18, 2009, 86 days after the submission was received.
What is the product code of K091887?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.