FDA 510(k)

DGA 牙根擴張器

K 號：K231210 · 2024-03-05

申請人Modern Dental Laboratory (Dg) Co., Ltd.

決定日期2024-03-05

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

DGA Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Modern Dental Laboratory (Dg) Co., Ltd.. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K231210. 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 DGA Abutment?

DGA Abutment is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Modern Dental Laboratory (Dg) Co., Ltd.. The 510(k) number is K231210.

When did DGA Abutment receive FDA 510(k) clearance?

DGA Abutment received FDA 510(k) clearance on 2024-03-05, under 510(k) number K231210.

Who is the listed applicant for DGA Abutment?

The FDA 510(k) record lists Modern Dental Laboratory (Dg) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DGA Abutment?

The FDA product code for DGA Abutment is NHA.

其他以 Modern Dental Laboratory (Dg) Co., Ltd. 為申請人之記錄

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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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