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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 the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2021-10-06 under 510(k) 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. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K202063.

When did TrusFIL Universal Composite Restorative receive FDA 510(k) clearance?

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

Who is the listed applicant for TrusFIL Universal Composite Restorative?

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

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

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

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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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.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.

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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