FDA 510(k)

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

N.º K: K212706 · 2021-12-13

Fecha de decisión2021-12-13

Código de productoOBR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Splintek, Inc. como solicitante

K250122SleepRight Snore Aid K212767SleepRight Select-Comfort Dental Guard K193577SleepRight ProRx Custom Dental Guard K172223SleepRight ProRx Custom Dental Guard

Dispositivos relacionados (Código: OBR)

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Fuente oficial

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