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FDA 510(k)

TrusFIL Universal Composite Restorative

K-Number: K202063 · 2021-10-06

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2021-10-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TrusFIL Universal Composite Restorative is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2021-10-06 under approval number K202063. 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 TrusFIL Universal Composite Restorative?

TrusFIL Universal Composite Restorative is a medical device that received FDA 510(k) clearance on 2021-10-06. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K202063.

When was TrusFIL Universal Composite Restorative approved by the FDA?

TrusFIL Universal Composite Restorative received FDA 510(k) clearance on 2021-10-06, under approval number K202063.

What company makes TrusFIL Universal Composite Restorative?

TrusFIL Universal Composite Restorative is manufactured by Rizhao Huge Biomaterials Company, Ltd..

What is the FDA product code for TrusFIL Universal Composite Restorative?

The FDA product code for TrusFIL Universal Composite Restorative is EBF.

Related Clinical Trials

NCT07524842 Clinical Performance of Three Different Restorative Materials NOT_YET_RECRUITING NCT07261735 Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy RECRUITING NCT05361746 Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs COMPLETED NCT07547904 Clinical Performance of Bioactive Bulk-Fill in Class II Restorations RECRUITING NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Other Devices by Rizhao Huge Biomaterials Company, Ltd.

K201790Dual Cure Resin Cement K201787Light Cure Dental Adhesive K221510TrusFIL-Flow Flowable Composite Restorative K221450Phosphoric Acid Etching Gel K233082TopCEM Dual Cure Resin Cement K230455Enamel Coating Resin

View all 13 devices →

Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

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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