Biouniversal PDF
FDA 510(k) K011022 · Ivoclar North America, Inc.
510(k) numberK011022
Submission
- Device name
- Biouniversal PDF
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- April 4, 2001
- Decision date
- May 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Biouniversal PDF cleared by the FDA?
Biouniversal PDF (K011022) received a 510(k) decision of Substantially Equivalent on May 2, 2001, 28 days after the submission was received.
What is the product code of K011022?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.