Kerecis 牙龈移植
K号: K192612 · 2020-11-13
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决定日期2020-11-13
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
Kerecis Gingiva Graft is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K192612. 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 Kerecis Gingiva Graft?
Kerecis Gingiva Graft is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Kerecis Limited. The 510(k) number is K192612.
When did Kerecis Gingiva Graft receive FDA 510(k) clearance?
Kerecis Gingiva Graft received FDA 510(k) clearance on 2020-11-13, under 510(k) number K192612.
Who is the listed applicant for Kerecis Gingiva Graft?
The FDA 510(k) record lists Kerecis Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kerecis Gingiva Graft?
The FDA product code for Kerecis Gingiva Graft 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Kerecis Limited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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