Cleared Traditional

K252004 - enCore Night Guard

K252004 · Encore Guards · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
151d
Days
-
Risk

K252004 is an FDA 510(k) clearance for the enCore Night Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Encore Guards (Santa Ana, US). The FDA issued a Cleared decision on November 25, 2025 after a review of 151 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 Encore Guards devices

FDA 510(k) Submission Details - K252004

510(k) Number K252004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2025
Decision Date November 25, 2025
Days to Decision 151 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
24d slower than avg
Panel avg: 127d · This submission: 151d
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 K252004.
ClenchNoMore (CNM-1 (Mixed sizing))
K252485 · 1987 Media Limited · Apr 2026
Owl Night Guard
K253641 · Owl Dental Lab, Inc. · Feb 2026
Remi Custom Night Guard
K251778 · Remi · Oct 2025
Dentemp Pro-Comfort Dental Guard
K250456 · Doc Brands, Inc. · May 2025
Anti Grinding Guard
K240810 · Xiamen Yizhou Imp. & Exp. Co., Ltd. · May 2024
Goyo Mouthpiece S
K232238 · Dimedikorea · Apr 2024