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FDA 510(k)

AA temp temporary restoration 3D printing photoreactive resin

K-Number: K191590 · 2020-05-05

ApplicantEnlighten Materials Co., Ltd.
Decision Date2020-05-05
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AA temp temporary restoration 3D printing photoreactive resin is the device name listed in this FDA 510(k) record. The listed applicant is Enlighten Materials Co., Ltd.. It received FDA 510(k) clearance on 2020-05-05 under 510(k) number K191590. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AA temp temporary restoration 3D printing photoreactive resin?

AA temp temporary restoration 3D printing photoreactive resin is a medical device that received FDA 510(k) clearance on 2020-05-05. The listed applicant is Enlighten Materials Co., Ltd.. The 510(k) number is K191590.

When did AA temp temporary restoration 3D printing photoreactive resin receive FDA 510(k) clearance?

AA temp temporary restoration 3D printing photoreactive resin received FDA 510(k) clearance on 2020-05-05, under 510(k) number K191590.

Who is the listed applicant for AA temp temporary restoration 3D printing photoreactive resin?

The FDA 510(k) record lists Enlighten Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AA temp temporary restoration 3D printing photoreactive resin?

The FDA product code for AA temp temporary restoration 3D printing photoreactive resin is EBG.

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.

NCT07632443PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary RestorationsRECRUITINGNCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITINGNCT07781241Color Stability and Tooth Sensitivity of CAD/CAM and Conventional Provisional RestorationsCOMPLETED

Other records listing Enlighten Materials Co., Ltd. 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.

K191591BB Base 3D printing resin for denture base

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials 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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