Ez-Fill Xpress Epoxy Root Canal Cement System
FDA 510(k) K063856 · Essential Dental Systems, Inc.
510(k) numberK063856
Submission
- Device name
- Ez-Fill Xpress Epoxy Root Canal Cement System
- Applicant
- Essential Dental Systems, Inc.
Great Neck, NY, US - Received
- December 28, 2006
- Decision date
- February 6, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ez-Fill Xpress Epoxy Root Canal Cement System cleared by the FDA?
Ez-Fill Xpress Epoxy Root Canal Cement System (K063856) received a 510(k) decision of Substantially Equivalent on February 6, 2007, 40 days after the submission was received.
What is the product code of K063856?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.