增强牙龈基质
K号: K250512 · 2025-12-05
广告
决定日期2025-12-05
产品代码NPL
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
Augmented Gingival Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K250512. 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 Augmented Gingival Matrix?
Augmented Gingival Matrix is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.. The 510(k) number is K250512.
When did Augmented Gingival Matrix receive FDA 510(k) clearance?
Augmented Gingival Matrix received FDA 510(k) clearance on 2025-12-05, under 510(k) number K250512.
Who is the listed applicant for Augmented Gingival Matrix?
The FDA 510(k) record lists Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Augmented Gingival Matrix?
The FDA product code for Augmented Gingival Matrix 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。
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 GmbHK252253Geistlich 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.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。
广告