Cleared Traditional

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (K212706) - FDA 510(k) Clearance

K212706 · Splintek, Inc. · Dental device
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Dec 2021
Decision
109d
Days
-
Risk

K212706 is an FDA 510(k) clearance for the SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Splintek, Inc. (Lenexa, US). The FDA issued a Cleared decision on December 13, 2021 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Splintek, Inc. devices

Submission Details

510(k) Number K212706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2021
Decision Date December 13, 2021
Days to Decision 109 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 127d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBR Mouthguard, Over-the-counter
Device Class -
Definition To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 19
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K212706.
Mouth Guard (ATG0603R)
K231865 · Reazeal Corp · Nov 2023
FBCC Night Guard
K221369 · Fbcc, Inc. · Nov 2022
Protect-It Custom Fit Dental Guard
K222424 · Doc Brands, Inc. · Oct 2022
NTI ClenchGuard
K211158 · Boyd Research, Inc. · Sep 2021
DenTek Fresh Protect Dental Guard
K202974 · Medtech Products, Inc. · Dec 2020
SleepRight ProRx Custom Dental Guard
K193577 · Splintek, Inc. · Jun 2020