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FDA 510(k)

Additive Manufacturing (Light Curing) Crown Bridge Resin

K-Number: K250497 · 2025-04-30

ApplicantAidite (Qinhuangdao) Technology Co., Ltd.
Decision Date2025-04-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Additive Manufacturing (Light Curing) Crown Bridge Resin is a medical device manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-30 under approval number K250497. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Additive Manufacturing (Light Curing) Crown Bridge Resin?

Additive Manufacturing (Light Curing) Crown Bridge Resin is a medical device that received FDA 510(k) clearance on 2025-04-30. It is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K250497.

When was Additive Manufacturing (Light Curing) Crown Bridge Resin approved by the FDA?

Additive Manufacturing (Light Curing) Crown Bridge Resin received FDA 510(k) clearance on 2025-04-30, under approval number K250497.

What company makes Additive Manufacturing (Light Curing) Crown Bridge Resin?

Additive Manufacturing (Light Curing) Crown Bridge Resin is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd..

What is the FDA product code for Additive Manufacturing (Light Curing) Crown Bridge Resin?

The FDA product code for Additive Manufacturing (Light Curing) Crown Bridge Resin is EBF.

Related Clinical Trials

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Related PubMed Literature

PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) 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) PMID: 40528079 The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey. Therapeutic innovation & regulatory science (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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