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FDA 510(k)

Transcend Bulk Fill Flowable Composite

K-Number: K262228 · 2026-07-01

ApplicantUltradent Products, Inc.
Decision Date2026-07-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Transcend Bulk Fill Flowable Composite is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K262228. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transcend Bulk Fill Flowable Composite?

Transcend Bulk Fill Flowable Composite is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K262228.

When did Transcend Bulk Fill Flowable Composite receive FDA 510(k) clearance?

Transcend Bulk Fill Flowable Composite received FDA 510(k) clearance on 2026-07-01, under 510(k) number K262228.

Who is the listed applicant for Transcend Bulk Fill Flowable Composite?

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

What is the FDA product code for Transcend Bulk Fill Flowable Composite?

The FDA product code for Transcend Bulk Fill Flowable Composite is EBF.

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.

NCT07212660A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous TeethRECRUITINGNCT07504393Clinical Performance of Four Restorative Materials in Primary MolarsNOT_YET_RECRUITINGNCT07524842Clinical Performance of Three Different Restorative MaterialsNOT_YET_RECRUITINGNCT07547904Clinical Performance of Bioactive Bulk-Fill in Class II RestorationsRECRUITINGNCT07612462Evaluation of the Clinical Performance of a Bulk Fill Resin Composite in Cuspal Coverage Restorations of Vital Posterior Teeth (RCT)ACTIVE_NOT_RECRUITINGNCT07720999Effect of Different Heating Protocols of Resin Composites on Pulp Condition (Randomized Controlled Trial)COMPLETED

Other records listing Ultradent Products, Inc. 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.

K261404UltraEZK240743Peak Universal BondK240694FORMA Composite (Shade A3D)K221909J-TempK220471VALO X, VALO X Accessory LensesK211905UltraCal XS

View all 12 devices →

Related Devices (Code: EBF)

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.

K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.K261357Grandio disc multicolorVoco 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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