Coltolux LED Curing Light
FDA 510(k) K040551 · Coltene/Whaledent, Inc.
510(k) numberK040551
Submission
- Device name
- Coltolux LED Curing Light
- Applicant
- Coltene/Whaledent, Inc.
New York, NY, US - Received
- March 2, 2004
- Decision date
- March 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Coltolux LED Curing Light cleared by the FDA?
Coltolux LED Curing Light (K040551) received a 510(k) decision of Substantially Equivalent on March 15, 2004, 13 days after the submission was received.
What is the product code of K040551?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.