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FDA 510(k)

Denture Base

K-Number: K260376 · 2026-05-06

ApplicantShandong Huge Dental Material Corporation
Decision Date2026-05-06
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Denture Base is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2026-05-06 under 510(k) number K260376. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Denture Base?

Denture Base is a medical device that received FDA 510(k) clearance on 2026-05-06. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K260376.

When did Denture Base receive FDA 510(k) clearance?

Denture Base received FDA 510(k) clearance on 2026-05-06, under 510(k) number K260376.

Who is the listed applicant for Denture Base?

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

What is the FDA product code for Denture Base?

The FDA product code for Denture Base is EBI.

Related Clinical Trials

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.

NCT07626827Clinical Performance and Quality of Life of 3D-Printed Complete Dentures Under Digital vs Hybrid Workflows: A Randomized Crossover TrialRECRUITING

Other records listing Shandong Huge Dental Material 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.

K260067Eternal Art Porcelain PowdersK251252NOBILCAM IMPAK DiscK220680Denture Base PolymersK213994Flexible BlockK201684A-Silicone for Bite RegistrationK181747Orthodontic Appliance

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Related Devices (Code: EBI)

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.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.

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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