FDA 510(k)

瑞士膠膜 X；瑞士膠膜 X 插孔

K 號：K250833 · 2025-04-15

決定日期2025-04-15

產品代碼NPL

諮詢委員會DE

決定相當於

器材摘要

SwissMembrane X; SwissMembrane X Socket is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-04-15 under 510(k) number K250833. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SwissMembrane X; SwissMembrane X Socket?

SwissMembrane X; SwissMembrane X Socket is a medical device that received FDA 510(k) clearance on 2025-04-15. The listed applicant is Geistlich Pharma AG. The 510(k) number is K250833.

When did SwissMembrane X; SwissMembrane X Socket receive FDA 510(k) clearance?

SwissMembrane X; SwissMembrane X Socket received FDA 510(k) clearance on 2025-04-15, under 510(k) number K250833.

Who is the listed applicant for SwissMembrane X; SwissMembrane X Socket?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SwissMembrane X; SwissMembrane X Socket?

The FDA product code for SwissMembrane X; SwissMembrane X Socket is NPL.

其他以 Geistlich Pharma AG 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。

K260364設備 300419 識別條 K260532德瑪吉德 K251323設備 104 粒子 K252253Geistlich Mucograft® /Geistlich Mucograft® 密封劑；Geistlich Fibro-Gide®K251062Geistlich Bio-Gide；Geistlich Bio-Gide® Shape；Geistlich Bio-Gide® Compressed；Geistlich Bio-Gide® Forte；Geistlich Bio-Gide® Perio；Geistlich Combi-Kit Collagen®；Geistlich Perio-System Combi Pack K251556設備 300423 粉末

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相關器械（代碼：NPL）

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。

K242817賈森膠膜Botiss Biomaterials GmbH K250512增強牙齦基質Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® 密封劑；Geistlich Fibro-Gide®Geistlich Pharma AG K251062Geistlich Bio-Gide；Geistlich Bio-Gide® Shape；Geistlich Bio-Gide® Compressed；Geistlich Bio-Gide® Forte；Geistlich Bio-Gide® Perio；Geistlich Combi-Kit Collagen®；Geistlich Perio-System Combi PackGeistlich Pharma AG K233203軟組織增強可吸收網格Collagen Matrix, Inc.K231513口內膠質Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

官方來源

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