DYNAMIS® Navigation System
K号: K252962 · 2026-01-12
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决定日期2026-01-12
产品代码OLO
咨询委员会NE
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器械摘要
DYNAMIS™ Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Promethean Restorative, LLC. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K252962. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DYNAMIS™ Navigation System?
DYNAMIS™ Navigation System is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Promethean Restorative, LLC. The 510(k) number is K252962.
When did DYNAMIS™ Navigation System receive FDA 510(k) clearance?
DYNAMIS™ Navigation System received FDA 510(k) clearance on 2026-01-12, under 510(k) number K252962.
Who is the listed applicant for DYNAMIS™ Navigation System?
The FDA 510(k) record lists Promethean Restorative, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DYNAMIS™ Navigation System?
The FDA product code for DYNAMIS™ Navigation System is OLO.
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列明Promethean Restorative, LLC为申报人的其他记录
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相关器械（代码：OLO）
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。
官方来源
在 FDA 数据库中查看 →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。
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