Paladon Ultra Powder (Pink), Paladon Ultra Liquid
FDA 510(k) K111832 · Heraeus Kulzer, LLC
510(k) numberK111832
Submission
- Device name
- Paladon Ultra Powder (Pink), Paladon Ultra Liquid
- Applicant
- Heraeus Kulzer, LLC
South Bend, IN, US - Received
- June 28, 2011
- Decision date
- September 29, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Paladon Ultra Powder (Pink), Paladon Ultra Liquid cleared by the FDA?
Paladon Ultra Powder (Pink), Paladon Ultra Liquid (K111832) received a 510(k) decision of Substantially Equivalent on September 29, 2011, 93 days after the submission was received.
What is the product code of K111832?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.