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FDA 510(k)

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

K-Number: K222741 · 2022-11-07

ApplicantHdi, Inc.
Decision Date2022-11-07
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is the device name listed in this FDA 510(k) record. The listed applicant is Hdi, Inc.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222741. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Hdi, Inc.. The 510(k) number is K222741.

When did DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) receive FDA 510(k) clearance?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222741.

Who is the listed applicant for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

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

The FDA product code for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is ELW.

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.

NCT06958289Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous SystemRECRUITINGNCT07246512A Comparative Analysis of Biomaterials for Retrograde Filling in Apical Surgery.COMPLETED

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.

K213339DENU Composite Resin, DENU Flow Resin

Related Devices (Code: ELW)

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.

K254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorDent4you AGK233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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