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FDA 510(k)

Well-Root PT

K-Number: K252285 · 2025-09-19

ApplicantVericom Co., Ltd.
Decision Date2025-09-19
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Well-Root PT is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K252285. 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 Well-Root PT?

Well-Root PT is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K252285.

When did Well-Root PT receive FDA 510(k) clearance?

Well-Root PT received FDA 510(k) clearance on 2025-09-19, under 510(k) number K252285.

Who is the listed applicant for Well-Root PT?

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

What is the FDA product code for Well-Root PT?

The FDA product code for Well-Root PT is KIF.

Other records listing Vericom 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.

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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.K251884One-Fil Putty InjectableMediclus 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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