Endoform 牙科膜
K号: K231305 · 2024-01-23
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决定日期2024-01-23
产品代码NPL
咨询委员会DE
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器械摘要
Endoform Dental Membrane is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K231305. 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 Endoform Dental Membrane?
Endoform Dental Membrane is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K231305.
When did Endoform Dental Membrane receive FDA 510(k) clearance?
Endoform Dental Membrane received FDA 510(k) clearance on 2024-01-23, under 510(k) number K231305.
Who is the listed applicant for Endoform Dental Membrane?
The FDA 510(k) record lists Aroa Biosurgery , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endoform Dental Membrane?
The FDA product code for Endoform Dental Membrane 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Aroa Biosurgery , Ltd.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。
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 AGK250833SwissMembrane X；SwissMembrane X 插座Geistlich Pharma AGK233203软组织增强可吸收基质Collagen Matrix, Inc.
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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