FDA 510(k)

KeyPrint 鍵牙基座

K 號：K241089 · 2024-10-24

決定日期2024-10-24

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

KeyPrint KeyDenture Base is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Industries. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K241089. 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 KeyPrint KeyDenture Base?

KeyPrint KeyDenture Base is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Keystone Industries. The 510(k) number is K241089.

When did KeyPrint KeyDenture Base receive FDA 510(k) clearance?

KeyPrint KeyDenture Base received FDA 510(k) clearance on 2024-10-24, under 510(k) number K241089.

Who is the listed applicant for KeyPrint KeyDenture Base?

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

What is the FDA product code for KeyPrint KeyDenture Base?

The FDA product code for KeyPrint KeyDenture Base is EBI.

其他以 Keystone Industries 為申請人之記錄

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。

K250489FP3D K183598KeyPrint KeySplint 软件設備 FDA、510(k)、PMA、NCT、PMID、識別碼及網址請保持原樣。

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。

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官方來源

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