FDA 510(k)

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA

K号: K252469 · 2025-11-06

决定日期2025-11-06

产品代码KLE

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决定实质等同

器械摘要

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA is the device name listed in this FDA 510(k) record. The listed applicant is Dmp Dental Industry S.A.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K252469. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA?

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Dmp Dental Industry S.A.. The 510(k) number is K252469.

When did MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA receive FDA 510(k) clearance?

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA received FDA 510(k) clearance on 2025-11-06, under 510(k) number K252469.

Who is the listed applicant for MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA?

The FDA 510(k) record lists Dmp Dental Industry S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA?

The FDA product code for MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA is KLE.

列明Dmp Dental Industry S.A.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。

K253248设备名称：Bright腔内衬 K192830Bright Temporary C&B

官方来源

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