D1 LED Curing Light, Spec 3, Dentronix LED 3000
FDA 510(k) K121093 · Dxm Co., Ltd.
510(k) numberK121093
Submission
- Device name
- D1 LED Curing Light, Spec 3, Dentronix LED 3000
- Applicant
- Dxm Co., Ltd.
Great Neck, NY, US - Received
- April 10, 2012
- Decision date
- November 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was D1 LED Curing Light, Spec 3, Dentronix LED 3000 cleared by the FDA?
D1 LED Curing Light, Spec 3, Dentronix LED 3000 (K121093) received a 510(k) decision of Substantially Equivalent on November 27, 2012, 231 days after the submission was received.
What is the product code of K121093?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.