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FDA 510(k)

ZenSeal Pro

K-Number: K252890 · 2026-01-07

ApplicantKerr Corporation
Decision Date2026-01-07
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZenSeal Pro is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K252890. 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 ZenSeal Pro?

ZenSeal Pro is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Kerr Corporation. The 510(k) number is K252890.

When did ZenSeal Pro receive FDA 510(k) clearance?

ZenSeal Pro received FDA 510(k) clearance on 2026-01-07, under 510(k) number K252890.

Who is the listed applicant for ZenSeal Pro?

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

What is the FDA product code for ZenSeal Pro?

The FDA product code for ZenSeal Pro is KIF.

Other records listing Kerr Corporation 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.K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom 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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