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FDA 510(k)

BB Base 3D printing resin for denture base

K-Number: K191591 · 2020-08-18

ApplicantEnlighten Materials Co., Ltd.
Decision Date2020-08-18
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BB Base 3D printing resin for denture base is a medical device manufactured by Enlighten Materials Co., Ltd.. It received FDA 510(k) clearance on 2020-08-18 under approval number K191591. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BB Base 3D printing resin for denture base?

BB Base 3D printing resin for denture base is a medical device that received FDA 510(k) clearance on 2020-08-18. It is manufactured by Enlighten Materials Co., Ltd.. The 510(k) number is K191591.

When was BB Base 3D printing resin for denture base approved by the FDA?

BB Base 3D printing resin for denture base received FDA 510(k) clearance on 2020-08-18, under approval number K191591.

What company makes BB Base 3D printing resin for denture base?

BB Base 3D printing resin for denture base is manufactured by Enlighten Materials Co., Ltd..

What is the FDA product code for BB Base 3D printing resin for denture base?

The FDA product code for BB Base 3D printing resin for denture base is EBI.

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Other Devices by Enlighten Materials Co., Ltd.

K191590AA temp temporary restoration 3D printing photoreactive resin

Related Devices (Code: EBI)

K161330Pour AcrylicDentsply Sirona K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc. K160498Dentivera Milling DiscDental Solutions, LLC K153590AvaDent Denture Base MaterialGlobal Dental Science K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries

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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