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FDA 510(k)

Once-Fil Flow

K-Number: K251283 · 2025-06-06

ApplicantMediclus Co., Ltd.
Decision Date2025-06-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Once-Fil Flow is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K251283. 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 Once-Fil Flow?

Once-Fil Flow is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K251283.

When did Once-Fil Flow receive FDA 510(k) clearance?

Once-Fil Flow received FDA 510(k) clearance on 2025-06-06, under 510(k) number K251283.

Who is the listed applicant for Once-Fil Flow?

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

What is the FDA product code for Once-Fil Flow?

The FDA product code for Once-Fil Flow is EBF.

Other records listing Mediclus 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.

K254201Any-CemK261728One-Fil LCK260485Any-EtchK260819Any-Com SealK253797One-StopK253167Any-Paste

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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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