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FDA 510(k)

NeoPEX™ Pre-Mixed Obturation Paste

K-Number: K253909 · 2026-09-04

ApplicantNuSmile, Ltd.
Decision Date2026-09-04
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NeoPEX™ Pre-Mixed Obturation Paste is the device name listed in this FDA 510(k) record. The listed applicant is NuSmile, Ltd.. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K253909. 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 NeoPEX™ Pre-Mixed Obturation Paste?

NeoPEX™ Pre-Mixed Obturation Paste is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is NuSmile, Ltd.. The 510(k) number is K253909.

When did NeoPEX™ Pre-Mixed Obturation Paste receive FDA 510(k) clearance?

NeoPEX™ Pre-Mixed Obturation Paste received FDA 510(k) clearance on 2026-09-04, under 510(k) number K253909.

Who is the listed applicant for NeoPEX™ Pre-Mixed Obturation Paste?

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

What is the FDA product code for NeoPEX™ Pre-Mixed Obturation Paste?

The FDA product code for NeoPEX™ Pre-Mixed Obturation Paste is KIF.

Other records listing NuSmile, 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.

K181917MTA2.3 MATERIALS

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.

K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.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.

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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