Iris - High Strength Glass Ceramic
FDA 510(k) K123615 · Dentsply Intl.
510(k) numberK123615
Submission
- Device name
- Iris - High Strength Glass Ceramic
- Applicant
- Dentsply Intl.
York, PA, US - Received
- November 23, 2012
- Decision date
- February 22, 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 Iris - High Strength Glass Ceramic cleared by the FDA?
Iris - High Strength Glass Ceramic (K123615) received a 510(k) decision of Substantially Equivalent on February 22, 2013, 91 days after the submission was received.
What is the product code of K123615?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.