FDA 510(k)

TSV BellaTek Express 及 BellaTek Flex 牙槽體

K 號：K192522 · 2019-12-09

決定日期2019-12-09

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

TSV BellaTek Express and BellaTek Flex Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, LLC. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K192522. 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 TSV BellaTek Express and BellaTek Flex Abutments?

TSV BellaTek Express and BellaTek Flex Abutments is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Biomet 3i, LLC. The 510(k) number is K192522.

When did TSV BellaTek Express and BellaTek Flex Abutments receive FDA 510(k) clearance?

TSV BellaTek Express and BellaTek Flex Abutments received FDA 510(k) clearance on 2019-12-09, under 510(k) number K192522.

Who is the listed applicant for TSV BellaTek Express and BellaTek Flex Abutments?

The FDA 510(k) record lists Biomet 3i, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSV BellaTek Express and BellaTek Flex Abutments?

The FDA product code for TSV BellaTek Express and BellaTek Flex Abutments is NHA.

其他以 Biomet 3i, LLC 為申請人之記錄

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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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