FDA 510(k)

Overjet 龋齿辅助-儿科

K号: K233738 · 2024-03-04

决定日期2024-03-04

产品代码MYN

咨询委员会RA

决定实质等同

器械摘要

Overjet Caries Assist-Pediatric is the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2024-03-04 under 510(k) number K233738. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Overjet Caries Assist-Pediatric?

Overjet Caries Assist-Pediatric is a medical device that received FDA 510(k) clearance on 2024-03-04. The listed applicant is Overjet, Inc.. The 510(k) number is K233738.

When did Overjet Caries Assist-Pediatric receive FDA 510(k) clearance?

Overjet Caries Assist-Pediatric received FDA 510(k) clearance on 2024-03-04, under 510(k) number K233738.

Who is the listed applicant for Overjet Caries Assist-Pediatric?

FDA 510(k)记录中列出Overjet, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Overjet Caries Assist-Pediatric?

The FDA product code for Overjet Caries Assist-Pediatric is MYN.

列明Overjet, Inc.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。

K261059Overjet 多图像龋齿和图表辅助设备 K253930Overjet 瞳孔智能成像系统 K251514Overjet CBCT 辅助 K241681Overjet 图像增强辅助 K241684Overjet 绘图辅助 K233590Overjet 绘图辅助

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。