Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
FDA 510(k) K231263 · Prevest Denpro Limited
510(k) numberK231263
Submission
- Device name
- Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
- Applicant
- Prevest Denpro Limited
Bari Brahmana, IN - Received
- May 2, 2023
- Decision date
- January 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT cleared by the FDA?
Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT (K231263) received a 510(k) decision of Substantially Equivalent on January 5, 2024, 248 days after the submission was received.
What is the product code of K231263?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.