Cleared Traditional

K252485 - ClenchNoMore (CNM-1 (Mixed sizing)) (FDA 510(k) Clearance)

Also includes:
ClenchNoMore (CNM-L (Large size)) ClenchNoMore (CNM-S (Small size))
K252485 · 1987 Media Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
246d
Days
-
Risk

K252485 is an FDA 510(k) clearance for the ClenchNoMore (CNM-1 (Mixed sizing)). Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by 1987 Media Limited (Walton-On-Thames, GB). The FDA issued a Cleared decision on April 10, 2026 after a review of 246 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 1987 Media Limited devices

Submission Details

510(k) Number K252485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2025
Decision Date April 10, 2026
Days to Decision 246 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
119d slower than avg
Panel avg: 127d · This submission: 246d
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 Consultant

MD Compliance Limited
Andrew Donn

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 44
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K252485.
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Dentemp Pro-Comfort Dental Guard
K250456 · Doc Brands, Inc. · May 2025
Anti Grinding Guard
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Goyo Mouthpiece S
K232238 · Dimedikorea · Apr 2024