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FDA 510(k)

One-Fil Putty Injectable

K-Number: K251884 · 2025-08-22

ApplicantMediclus Co., Ltd.
Decision Date2025-08-22
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

One-Fil Putty Injectable 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 2025-08-22 under 510(k) number K251884. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the One-Fil Putty Injectable?

One-Fil Putty Injectable is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K251884.

When did One-Fil Putty Injectable receive FDA 510(k) clearance?

One-Fil Putty Injectable received FDA 510(k) clearance on 2025-08-22, under 510(k) number K251884.

Who is the listed applicant for One-Fil Putty Injectable?

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 One-Fil Putty Injectable?

The FDA product code for One-Fil Putty Injectable is KIF.

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: KIF)

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.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251390MTA vptVoco GmbH

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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