FDA 510(k)

SleepRight ProRx + 定制牙套，SleepRight ProRx 定制牙套

K号: K212706 · 2021-12-13

决定日期2021-12-13

产品代码OBR

决定实质等同

器械摘要

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom 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 2021-12-13 under 510(k) number K212706. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard?

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Splintek, Inc.. The 510(k) number is K212706.

When did SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard receive FDA 510(k) clearance?

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212706.

Who is the listed applicant for SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom 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 ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard?

The FDA product code for SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard is OBR. This falls under the Orthopedic category.

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。

K250122SleepRight 喉咙呼吸辅助器 K212767SleepRight Select-Comfort牙套 K193577SleepRight ProRx 定制牙套 K172223SleepRight ProRx 定制牙套

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。