SleepRight ProRx Custom Dental Guard
K-Number: K193577 · 2020-06-01
Device Summary
SleepRight ProRx Custom Dental Guard is a medical device manufactured by Splintek, Inc.. It received FDA 510(k) clearance on 2020-06-01 under approval number K193577. 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.
Frequently Asked Questions
What is the SleepRight ProRx Custom Dental Guard?
SleepRight ProRx Custom Dental Guard is a medical device that received FDA 510(k) clearance on 2020-06-01. It is manufactured by Splintek, Inc.. The 510(k) number is K193577.
When was SleepRight ProRx Custom Dental Guard approved by the FDA?
SleepRight ProRx Custom Dental Guard received FDA 510(k) clearance on 2020-06-01, under approval number K193577.
What company makes SleepRight ProRx Custom Dental Guard?
SleepRight ProRx Custom Dental Guard is manufactured by Splintek, Inc..
What is the FDA product code for SleepRight ProRx Custom Dental Guard?
The FDA product code for SleepRight ProRx Custom Dental Guard is OBR. This falls under the Orthopedic category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.