Vitablocs, Model VX55-****
FDA 510(k) K090644 · Vita Zahnfabrik H.Rauter GmbH & Co.
510(k) numberK090644
Submission
- Device name
- Vitablocs, Model VX55-****
- Applicant
- Vita Zahnfabrik H.Rauter GmbH & Co.
Brea, CA, US - Received
- March 10, 2009
- Decision date
- March 31, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Vitablocs, Model VX55-**** cleared by the FDA?
Vitablocs, Model VX55-**** (K090644) received a 510(k) decision of Substantially Equivalent on March 31, 2009, 21 days after the submission was received.
What is the product code of K090644?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.