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FDA 510(k)

Denture Base

K-Number: K260376 · 2026-05-06

Decision Date2026-05-06
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Denture Base is a medical device manufactured by Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2026-05-06 under approval number K260376. 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?

Denture Base is a medical device that received FDA 510(k) clearance on 2026-05-06. It is manufactured by Shandong Huge Dental Material Corporation. The 510(k) number is K260376.

When was Denture Base approved by the FDA?

Denture Base received FDA 510(k) clearance on 2026-05-06, under approval number K260376.

What company makes Denture Base?

Denture Base is manufactured by Shandong Huge Dental Material Corporation.

What is the FDA product code for Denture Base?

The FDA product code for Denture Base is EBI.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.