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FDA 510(k)

Additively Manufactured Denture Resin

K-Number: K242884 · 2024-11-22

ApplicantAidite (Qinhuangdao) Technology Co., Ltd.
Decision Date2024-11-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Additively Manufactured Denture Resin is a medical device manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-22 under approval number K242884. 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 Additively Manufactured Denture Resin?

Additively Manufactured Denture Resin is a medical device that received FDA 510(k) clearance on 2024-11-22. It is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K242884.

When was Additively Manufactured Denture Resin approved by the FDA?

Additively Manufactured Denture Resin received FDA 510(k) clearance on 2024-11-22, under approval number K242884.

What company makes Additively Manufactured Denture Resin?

Additively Manufactured Denture Resin is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd..

What is the FDA product code for Additively Manufactured Denture Resin?

The FDA product code for Additively Manufactured Denture Resin is EBI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 41034609 Influence of geometry, reinforcement, and sterilisation on the dimensional accuracy of additively manufactured carbon fibre-reinforced nylon composites. Scientific reports (2025)

Other Devices by Aidite (Qinhuangdao) Technology Co., Ltd.

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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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