FDA 510(k)

Proxeo ULTRA (PB-510、PB-520 及 PB-530)

K 號：K223173 · 2023-07-14

決定日期2023-07-14

產品代碼ELC

諮詢委員會DE

決定相當於

器材摘要

Proxeo ULTRA (PB-510, PB-520 and PB-530) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoss GmbH. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K223173. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Proxeo ULTRA (PB-510, PB-520 and PB-530)?

Proxeo ULTRA (PB-510, PB-520 and PB-530) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is W&H Dentalwerk Buermoss GmbH. The 510(k) number is K223173.

When did Proxeo ULTRA (PB-510, PB-520 and PB-530) receive FDA 510(k) clearance?

Proxeo ULTRA (PB-510, PB-520 and PB-530) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K223173.

Who is the listed applicant for Proxeo ULTRA (PB-510, PB-520 and PB-530)?

The FDA 510(k) record lists W&H Dentalwerk Buermoss GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proxeo ULTRA (PB-510, PB-520 and PB-530)?

The FDA product code for Proxeo ULTRA (PB-510, PB-520 and PB-530) is ELC.

其他以 W&H Dentalwerk Buermoss GmbH 為申請人之記錄

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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相關器械（代碼：ELC）

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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