FDA 510(k)

牙科LT舒適树脂

K 號：K232087 · 2024-02-16

決定日期2024-02-16

產品代碼MQC

決定相當於

器材摘要

Dental LT Comfort Resin is the device name listed in this FDA 510(k) record. The listed applicant is Formlabs Ohio, Inc.. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K232087. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental LT Comfort Resin?

Dental LT Comfort Resin is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Formlabs Ohio, Inc.. The 510(k) number is K232087.

When did Dental LT Comfort Resin receive FDA 510(k) clearance?

Dental LT Comfort Resin received FDA 510(k) clearance on 2024-02-16, under 510(k) number K232087.

Who is the listed applicant for Dental LT Comfort Resin?

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

What is the FDA product code for Dental LT Comfort Resin?

The FDA product code for Dental LT Comfort Resin is MQC.

其他以 Formlabs Ohio, Inc. 為申請人之記錄

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相關器械（代碼：MQC）

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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