FDA 510(k)

Saremco Print CROWNTEC

K号: K213343 · 2022-01-21

决定日期2022-01-21

产品代码EBF

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决定实质等同

器械摘要

Saremco Print CROWNTEC is the device name listed in this FDA 510(k) record. The listed applicant is Saremco Dental AG. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K213343. 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 Saremco Print CROWNTEC?

Saremco Print CROWNTEC is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Saremco Dental AG. The 510(k) number is K213343.

When did Saremco Print CROWNTEC receive FDA 510(k) clearance?

Saremco Print CROWNTEC received FDA 510(k) clearance on 2022-01-21, under 510(k) number K213343.

Who is the listed applicant for Saremco Print CROWNTEC?

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

What is the FDA product code for Saremco Print CROWNTEC?

The FDA product code for Saremco Print CROWNTEC is EBF.

列明Saremco Dental AG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。

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