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FDA 510(k)

DSM Biomedical 猪心包牙膜

K号: K160474 · 2016-06-07

申请人Kensey Nash Corporation Dba Dsm Biomedical
决定日期2016-06-07
产品代码NPL
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决定实质等同

器械摘要

DSM Biomedical Porcine Pericardium Dental Membrane is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K160474. 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 DSM Biomedical Porcine Pericardium Dental Membrane?

DSM Biomedical Porcine Pericardium Dental Membrane is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. The 510(k) number is K160474.

When did DSM Biomedical Porcine Pericardium Dental Membrane receive FDA 510(k) clearance?

DSM Biomedical Porcine Pericardium Dental Membrane received FDA 510(k) clearance on 2016-06-07, under 510(k) number K160474.

Who is the listed applicant for DSM Biomedical Porcine Pericardium Dental Membrane?

The FDA 510(k) record lists Kensey Nash Corporation Dba Dsm Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSM Biomedical Porcine Pericardium Dental Membrane?

The FDA product code for DSM Biomedical Porcine Pericardium 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Kensey Nash Corporation Dba Dsm Biomedical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。

K173572DSM Biomedical 磷酸钙水泥微球K173362DSM 生物医学磷酸钙水泥K170245DSM Biomedical 牙科骨移植

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

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