ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))— 510(k) K252485

Name: FDA 510(k) clearance K252485
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Substantially Equivalent

1987 Media Limited

FDA 510(k) clearance K252485 for ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)), Substantially Equivalent on 2026-04-10. Applicant: 1987 Media Limited. Device class: Unclassified.

Summary

ClenchNoMore is an over-the-counter mouthguard in three sizing options: mixed (CNM-1), large (CNM-L), and small (CNM-S). Product code OBR covers OTC mouthguards meant to protect the teeth and reduce damage from bruxing or nighttime grinding.

The record lists the device class as U, for unclassified, with no regulation number, and the advisory panel as Unknown. The Dental panel reviewed it as a Traditional 510(k).

1987 Media Limited filed from Walton-on-Thames, United Kingdom. Review took 246 days (August 7, 2025 to April 10, 2026).

Clearance details

Applicant: 1987 Media Limited
Product code: Product code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-08-07
Decision date: 2026-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walton-On-Thames, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.