Demi Ultra
FDA 510(k) K123468 · Kerr Corporation
510(k) numberK123468
Submission
- Device name
- Demi Ultra
- Applicant
- Kerr Corporation
Orange, CA, US - Received
- November 9, 2012
- Decision date
- March 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Demi Ultra cleared by the FDA?
Demi Ultra (K123468) received a 510(k) decision of Substantially Equivalent on March 20, 2013, 131 days after the submission was received.
What is the product code of K123468?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.