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FDA 510(k)

DENU Composite Resin, DENU Flow Resin

K-Number: K213339 · 2022-09-23

ApplicantHdi, Inc.
Decision Date2022-09-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENU Composite Resin, DENU Flow Resin is the device name listed in this FDA 510(k) record. The listed applicant is Hdi, Inc.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K213339. 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 DENU Composite Resin, DENU Flow Resin?

DENU Composite Resin, DENU Flow Resin is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Hdi, Inc.. The 510(k) number is K213339.

When did DENU Composite Resin, DENU Flow Resin receive FDA 510(k) clearance?

DENU Composite Resin, DENU Flow Resin received FDA 510(k) clearance on 2022-09-23, under 510(k) number K213339.

Who is the listed applicant for DENU Composite Resin, DENU Flow Resin?

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

What is the FDA product code for DENU Composite Resin, DENU Flow Resin?

The FDA product code for DENU Composite Resin, DENU Flow Resin is EBF.

Other records listing Hdi, 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.

K222741DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

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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