FDA 510(k)

DYNAMIS™導航系統

K 號：K252962 · 2026-01-12

決定日期2026-01-12

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

DYNAMIS™ Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Promethean Restorative, LLC. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K252962. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DYNAMIS™ Navigation System?

DYNAMIS™ Navigation System is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Promethean Restorative, LLC. The 510(k) number is K252962.

When did DYNAMIS™ Navigation System receive FDA 510(k) clearance?

DYNAMIS™ Navigation System received FDA 510(k) clearance on 2026-01-12, under 510(k) number K252962.

Who is the listed applicant for DYNAMIS™ Navigation System?

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

What is the FDA product code for DYNAMIS™ Navigation System?

The FDA product code for DYNAMIS™ Navigation System is OLO.

其他以 Promethean Restorative, LLC 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：OLO）

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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