SwissMembrane X；SwissMembrane X 插座
K号: K250833 · 2025-04-15
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决定日期2025-04-15
产品代码NPL
咨询委员会DE
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Geistlich Pharma AG为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K260364设备300419条带K260532Derma-GideK251323设备104颗粒K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; 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 PackK251556设备300423颗粒
相关器械（代码：NPL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K242817Jason 膜Botiss Biomaterials GmbHK250512增强牙龈基质Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AGK251062Geistlich 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 AGK233203软组织增强可吸收基质Collagen Matrix, Inc.K231513口腔基质Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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