Ortholux Visible Light Curing Unit
FDA 510(k) K880392 · Unitek Corp.
510(k) numberK880392
Submission
- Device name
- Ortholux Visible Light Curing Unit
- Applicant
- Unitek Corp.
Monrovia, CA, US - Received
- January 29, 1988
- Decision date
- April 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Ortholux Visible Light Curing Unit cleared by the FDA?
Ortholux Visible Light Curing Unit (K880392) received a 510(k) decision of Substantially Equivalent on April 7, 1988, 69 days after the submission was received.
What is the product code of K880392?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.