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FDA 510(k)

EsFlow PLUS

K-Number: K250317 · 2025-05-30

ApplicantSpident Co., Ltd.
Decision Date2025-05-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EsFlow PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K250317. 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 EsFlow PLUS?

EsFlow PLUS is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Spident Co., Ltd.. The 510(k) number is K250317.

When did EsFlow PLUS receive FDA 510(k) clearance?

EsFlow PLUS received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250317.

Who is the listed applicant for EsFlow PLUS?

The FDA 510(k) record lists Spident Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EsFlow PLUS?

The FDA product code for EsFlow PLUS is EBF.

Other records listing Spident Co., Ltd. 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.

K261129OrthoFitK250566EsCem RMGIK242702VioSealK242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)K241445K-Bond UniversalK231523EsCom250

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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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