Cleared Traditional

K212706 - SleepRight ProRx + Custom Dental Guard

K212706 · Splintek, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K212706

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.

OBR Device Classification - Class 0,

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