SmileGuard
K号: K220894 · 2022-06-10
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器械摘要
SmileGuard is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K220894. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
常见问题
What is the SmileGuard?
SmileGuard is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Envisiontec GmbH. The 510(k) number is K220894.
When did SmileGuard receive FDA 510(k) clearance?
SmileGuard received FDA 510(k) clearance on 2022-06-10, under 510(k) number K220894.
Who is the listed applicant for SmileGuard?
The FDA 510(k) record lists Envisiontec GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmileGuard?
The FDA product code for SmileGuard is MQC.
相关临床试验
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列明Envisiontec GmbH为申报人的其他记录
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相关器械（代码：MQC）
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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