Cleared Traditional

K193577 - SleepRight ProRx Custom Dental Guard

K193577 · Splintek, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
161d
Days
-
Risk

K193577 is an FDA 510(k) clearance for the 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 June 1, 2020 after a review of 161 days - an extended review cycle.

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 - K193577

510(k) Number K193577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date June 01, 2020
Days to Decision 161 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
34d slower than avg
Panel avg: 127d · This submission: 161d
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 K193577.
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
K212706 · Splintek, Inc. · Dec 2021
NTI ClenchGuard
K211158 · Boyd Research, Inc. · Sep 2021
DenTek Fresh Protect Dental Guard
K202974 · Medtech Products, Inc. · Dec 2020
ClenchGuard
K181005 · Boyd Research, Inc. · Jan 2020
CustMBite Dental Guard
K183315 · Dental Choice Holdings, LLC · Aug 2019
LunaGuard Nighttime Dental Protector
K191033 · Mckeon Products · Aug 2019