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FDA 510(k)

SleepRight ProRx Custom Dental Guard

K-Number: K193577 · 2020-06-01

ApplicantSplintek, Inc.
Decision Date2020-06-01
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

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 2020-06-01 under 510(k) 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. The listed applicant is Splintek, Inc.. The 510(k) number is K193577.

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

SleepRight ProRx Custom Dental Guard received FDA 510(k) clearance on 2020-06-01, under 510(k) number K193577.

Who is the listed applicant for 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?

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

Other records listing Splintek, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250122SleepRight Snore AidK212767SleepRight Select-Comfort Dental GuardK212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardK172223SleepRight ProRx Custom Dental Guard

Related Devices (Code: OBR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media LimitedK253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore GuardsK251778Remi Custom Night GuardRemiK250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.

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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