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FDA 510(k)

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

K-Number: K212706 · 2021-12-13

ApplicantSplintek, Inc.
Decision Date2021-12-13
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard is a medical device manufactured by Splintek, Inc.. It received FDA 510(k) clearance on 2021-12-13 under approval 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.

Frequently Asked Questions

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. It is manufactured by Splintek, Inc.. The 510(k) number is K212706.

When was SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard approved by the FDA?

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

What company makes SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard?

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, 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.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07359638 Impact of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2 RECRUITING NCT07493200 The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment ACTIVE_NOT_RECRUITING

Other Devices by Splintek, Inc.

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

Related Devices (Code: OBR)

K150492Ora-GUARD Dental Grind GuardBite Tech, Inc. K172223SleepRight ProRx Custom Dental GuardSplintek, Inc. K180933DenTek Ultimate Dental GuardMedtech Products, Inc. K172452BruxorSleep Specialties, LLC K183315CustMBite Dental GuardDental Choice Holdings, LLC K191033LunaGuard Nighttime Dental ProtectorMckeon Products

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.

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