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FDA 510(k)

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

K-Number: K231263 · 2024-01-05

ApplicantPrevest Denpro Limited
Decision Date2024-01-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT is a medical device manufactured by Prevest Denpro Limited. It received FDA 510(k) clearance on 2024-01-05 under approval number K231263. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT is a medical device that received FDA 510(k) clearance on 2024-01-05. It is manufactured by Prevest Denpro Limited. The 510(k) number is K231263.

When was Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT approved by the FDA?

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT received FDA 510(k) clearance on 2024-01-05, under approval number K231263.

What company makes Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT is manufactured by Prevest Denpro Limited.

What is the FDA product code for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

The FDA product code for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT is EBF.

Other Devices by Prevest Denpro Limited

K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal K233273C&B Ceramic; C&B Permanent; C&B Interim

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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