FDA 510(k)

Primevision 3D

K 號：K253959 · 2026-02-05

決定日期2026-02-05

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

Primevision 3D is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2026-02-05 under 510(k) number K253959. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Primevision 3D?

Primevision 3D is a medical device that received FDA 510(k) clearance on 2026-02-05. The listed applicant is Dentsply Sirona. The 510(k) number is K253959.

When did Primevision 3D receive FDA 510(k) clearance?

Primevision 3D received FDA 510(k) clearance on 2026-02-05, under 510(k) number K253959.

Who is the listed applicant for Primevision 3D?

FDA 510(k) 記錄將 Dentsply Sirona 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Primevision 3D?

The FDA product code for Primevision 3D is OAS.

其他以 Dentsply Sirona 為申請人之記錄

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相關器械（代碼：OAS）

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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