FDA 510(k)

OSSIX Breeze

K号: K212509 · 2022-07-18

决定日期2022-07-18

产品代码NPL

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决定实质等同

器械摘要

OSSIX Breeze is the device name listed in this FDA 510(k) record. The listed applicant is Datum Dental, Ltd.. It received FDA 510(k) clearance on 2022-07-18 under 510(k) number K212509. 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 OSSIX Breeze?

OSSIX Breeze is a medical device that received FDA 510(k) clearance on 2022-07-18. The listed applicant is Datum Dental, Ltd.. The 510(k) number is K212509.

When did OSSIX Breeze receive FDA 510(k) clearance?

OSSIX Breeze received FDA 510(k) clearance on 2022-07-18, under 510(k) number K212509.

Who is the listed applicant for OSSIX Breeze?

The FDA 510(k) record lists Datum Dental, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSIX Breeze?

The FDA product code for OSSIX Breeze is NPL.

列明Datum Dental, 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。

K163714OSSIX BONE K160281OSSIX PLUS K153549OSSIX VOLUMAX

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 GmbH K250512增强牙龈基质Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG 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 PackGeistlich Pharma AG K250833SwissMembrane X；SwissMembrane X 插座Geistlich Pharma AG K233203软组织增强可吸收基质Collagen Matrix, Inc.

官方来源

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