Cleared Traditional

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

K231263 · Prevest Denpro Limited · Dental
Jan 2024
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K231263 is an FDA 510(k) clearance for the Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on January 5, 2024, 248 days after receiving the submission on May 2, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K231263 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2023
Decision Date January 05, 2024
Days to Decision 248 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690

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