Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2020-08-18 under 510(k) 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. The listed applicant is Enlighten Materials Co., Ltd.. The 510(k) number is K191591.

When did BB Base 3D printing resin for denture base receive FDA 510(k) clearance?

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

Who is the listed applicant for BB Base 3D printing resin for denture base?

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 BB Base 3D printing resin for denture base?

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

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.

NCT07626827Clinical Performance and Quality of Life of 3D-Printed Complete Dentures Under Digital vs Hybrid Workflows: A Randomized Crossover TrialRECRUITING

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.

K191590AA temp temporary restoration 3D printing photoreactive resin

Related Devices (Code: EBI)

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.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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.

↑