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

FDA 510(k)

Denture Base Resin DT20

K-Number: K250946 · 2025-03-31

Decision Date2025-03-31
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Denture Base Resin DT20 is a medical device manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-31 under approval number K250946. 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 Denture Base Resin DT20?

Denture Base Resin DT20 is a medical device that received FDA 510(k) clearance on 2025-03-31. It is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. The 510(k) number is K250946.

When was Denture Base Resin DT20 approved by the FDA?

Denture Base Resin DT20 received FDA 510(k) clearance on 2025-03-31, under approval number K250946.

What company makes Denture Base Resin DT20?

Denture Base Resin DT20 is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd..

What is the FDA product code for Denture Base Resin DT20?

The FDA product code for Denture Base Resin DT20 is EBI.

Other Devices by Hangzhou SHINING3D Dental Technology Co., Ltd.

Related Devices (Code: EBI)

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.