FDA 510(k)

Prevest Denpro 腔隙衬垫（Apacal ART，Cal LC，Calcigel，CalUltra）

K号: K212475 · 2022-05-13

决定日期2022-05-13

产品代码EJK

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决定实质等同

器械摘要

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K212475. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Prevest Denpro Limited. The 510(k) number is K212475.

When did Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) receive FDA 510(k) clearance?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) received FDA 510(k) clearance on 2022-05-13, under 510(k) number K212475.

Who is the listed applicant for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

The FDA 510(k) record lists Prevest Denpro Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

The FDA product code for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is EJK.

列明Prevest Denpro Limited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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