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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 the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2024-01-05 under 510(k) 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. The listed applicant is Prevest Denpro Limited. The 510(k) number is K231263.

When did Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT receive FDA 510(k) clearance?

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

Who is the listed applicant for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

The FDA 510(k) record lists Prevest Denpro Limited as the applicant. This does not by itself establish the device manufacturer.

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 records listing Prevest Denpro Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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