FDA 510(k)

AMADEO, M-UK1015（包括附件和配件）

K号: K213221 · 2022-05-26

决定日期2022-05-26

产品代码ERL

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

AMADEO, M-UK1015 (incl. attachments and accessories) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoss GmbH. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K213221. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AMADEO, M-UK1015 (incl. attachments and accessories)?

AMADEO, M-UK1015 (incl. attachments and accessories) is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is W&H Dentalwerk Buermoss GmbH. The 510(k) number is K213221.

When did AMADEO, M-UK1015 (incl. attachments and accessories) receive FDA 510(k) clearance?

AMADEO, M-UK1015 (incl. attachments and accessories) received FDA 510(k) clearance on 2022-05-26, under 510(k) number K213221.

Who is the listed applicant for AMADEO, M-UK1015 (incl. attachments and accessories)?

The FDA 510(k) record lists W&H Dentalwerk Buermoss GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMADEO, M-UK1015 (incl. attachments and accessories)?

The FDA product code for AMADEO, M-UK1015 (incl. attachments and accessories) is ERL.

列明W&H Dentalwerk Buermoss GmbH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。

K223173Proxeo ULTRA (PB-510, PB-520 和 PB-530)

相关器械（代码：ERL）

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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官方来源

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