FDA 510(k)

DESS 齿科智能解決方案

K 號：K242340 · 2024-11-05

決定日期2024-11-05

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

DESS Dental Smart Solutions is the device name listed in this FDA 510(k) record. The listed applicant is Terrats Medical SL. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K242340. 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 DESS Dental Smart Solutions?

DESS Dental Smart Solutions is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Terrats Medical SL. The 510(k) number is K242340.

When did DESS Dental Smart Solutions receive FDA 510(k) clearance?

DESS Dental Smart Solutions received FDA 510(k) clearance on 2024-11-05, under 510(k) number K242340.

Who is the listed applicant for DESS Dental Smart Solutions?

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

What is the FDA product code for DESS Dental Smart Solutions?

The FDA product code for DESS Dental Smart Solutions is NHA.

其他以 Terrats Medical SL 為申請人之記錄

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K260564DESS 齿科智能解決方案 K253804DESS 齿科智能解決方案 K251547DESS 齿科智能解決方案 K252384DESS® 齿科智能解決方案 K251280DESS® 齿科植體 K250639DESS 齿科智能解決方案

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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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