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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 a medical device manufactured by Enlighten Materials Co., Ltd.. It received FDA 510(k) clearance on 2020-05-05 under approval 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. It is manufactured by Enlighten Materials Co., Ltd.. The 510(k) number is K191590.

When was AA temp temporary restoration 3D printing photoreactive resin approved by the FDA?

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

What company makes AA temp temporary restoration 3D printing photoreactive resin?

AA temp temporary restoration 3D printing photoreactive resin is manufactured by Enlighten Materials Co., Ltd..

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.

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Other Devices by Enlighten Materials Co., Ltd.

K191591BB Base 3D printing resin for denture base

Related Devices (Code: EBG)

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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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