FDA 510(k)

Omnichroma 流量批量

K号: K203598 · 2021-02-03

决定日期2021-02-03

产品代码EBF

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决定实质等同

器械摘要

Omnichroma Flow Bulk is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2021-02-03 under 510(k) number K203598. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Omnichroma Flow Bulk?

Omnichroma Flow Bulk is a medical device that received FDA 510(k) clearance on 2021-02-03. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K203598.

When did Omnichroma Flow Bulk receive FDA 510(k) clearance?

Omnichroma Flow Bulk received FDA 510(k) clearance on 2021-02-03, under 510(k) number K203598.

Who is the listed applicant for Omnichroma Flow Bulk?

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

What is the FDA product code for Omnichroma Flow Bulk?

The FDA product code for Omnichroma Flow Bulk is EBF.

列明Tokuyama Dental Corporation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。

K203760徳永康新型通用粘合剂II K193537Omnichroma 流量 K190940徳永山Rebase III K180613Estelite通用流量 K173275OMNICHROMA K171226TOKUYAMA UNIVERSAL BOND

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官方来源

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