Vita Suprinity(R)
FDA 510(k) K132070 · Vita Zahnfabrik H.Rauter GmbH & Co.
510(k) numberK132070
Submission
- Device name
- Vita Suprinity(R)
- Applicant
- Vita Zahnfabrik H.Rauter GmbH & Co.
Brea, CA, US - Received
- July 3, 2013
- Decision date
- January 31, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vita Suprinity(R) cleared by the FDA?
Vita Suprinity(R) (K132070) received a 510(k) decision of Substantially Equivalent on January 31, 2014, 212 days after the submission was received.
What is the product code of K132070?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.