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FDA 510(k)

DB 4000 高衝擊牙托基座

K 號:K260569 · 2026-06-02

申請人Carbon, Inc.
決定日期2026-06-02
產品代碼EBI
諮詢委員會DE
決定相當於

器材摘要

DB 4000 High Impact Denture Base is the device name listed in this FDA 510(k) record. The listed applicant is Carbon, Inc.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K260569. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DB 4000 High Impact Denture Base?

DB 4000 High Impact Denture Base is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Carbon, Inc.. The 510(k) number is K260569.

When did DB 4000 High Impact Denture Base receive FDA 510(k) clearance?

DB 4000 High Impact Denture Base received FDA 510(k) clearance on 2026-06-02, under 510(k) number K260569.

Who is the listed applicant for DB 4000 High Impact Denture Base?

The FDA 510(k) record lists Carbon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DB 4000 High Impact Denture Base?

The FDA product code for DB 4000 High Impact Denture Base is EBI.

相關臨床試驗

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相關器械(代碼:EBI)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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