FDA 510(k)

Oneday Implant 牙根擴張體

K 號：K231753 · 2024-02-21

決定日期2024-02-21

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Oneday Implant Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Oneday Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-02-21 under 510(k) number K231753. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Oneday Implant Abutment?

Oneday Implant Abutment is a medical device that received FDA 510(k) clearance on 2024-02-21. The listed applicant is Oneday Biotech Co., Ltd.. The 510(k) number is K231753.

When did Oneday Implant Abutment receive FDA 510(k) clearance?

Oneday Implant Abutment received FDA 510(k) clearance on 2024-02-21, under 510(k) number K231753.

Who is the listed applicant for Oneday Implant Abutment?

The FDA 510(k) record lists Oneday Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oneday Implant Abutment?

The FDA product code for Oneday Implant Abutment is NHA.

其他以 Oneday Biotech Co., Ltd. 為申請人之記錄

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K222946Oneday迷你植入系統

相關器械（代碼：NHA）

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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