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FDA 510(k)

Legacy2、Legacy3、Legacy4、簡單Legacy2、簡單Legacy3 牙齒植體;Legacy2、Legacy3、Legacy4 座標器安裝座

K 號:K192221 · 2020-06-25

決定日期2020-06-25
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K192221. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts?

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K192221.

When did Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts receive FDA 510(k) clearance?

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts received FDA 510(k) clearance on 2020-06-25, under 510(k) number K192221.

Who is the listed applicant for Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts?

The FDA product code for Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts is DZE.

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其他以 Implant Direct Sybron Manufacturing, LLC 為申請人之記錄

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相關器械(代碼:DZE)

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。

官方來源

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