FDA 510(k)

SleepRight Select-Comfort牙套

K号: K212767 · 2021-12-22

决定日期2021-12-22

产品代码MQC

决定实质等同

器械摘要

SleepRight Select-Comfort Dental Guard is the device name listed in this FDA 510(k) record. The listed applicant is Splintek, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K212767. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the SleepRight Select-Comfort Dental Guard?

SleepRight Select-Comfort Dental Guard is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Splintek, Inc.. The 510(k) number is K212767.

When did SleepRight Select-Comfort Dental Guard receive FDA 510(k) clearance?

SleepRight Select-Comfort Dental Guard received FDA 510(k) clearance on 2021-12-22, under 510(k) number K212767.

Who is the listed applicant for SleepRight Select-Comfort Dental Guard?

The FDA 510(k) record lists Splintek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SleepRight Select-Comfort Dental Guard?

The FDA product code for SleepRight Select-Comfort Dental Guard is MQC.

列明Splintek, 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。

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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。