Contec Light
FDA 510(k) K030641 · Dentaurum
510(k) numberK030641
Submission
- Device name
- Contec Light
- Applicant
- Dentaurum
Newtown, PA, US - Received
- February 28, 2003
- Decision date
- June 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Contec Light cleared by the FDA?
Contec Light (K030641) received a 510(k) decision of Substantially Equivalent on June 10, 2003, 102 days after the submission was received.
What is the product code of K030641?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.