1987 Media Limited · Class U · Cleared Apr 10, 2026
| K-number | K252485 |
| Device name | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) |
| Applicant | 1987 Media Limited |
| Product code | OBR |
| Device class | Class U |
| Decision date | Apr 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
ClenchNoMore is an over-the-counter mouthguard made of thermoplastic ethylene-vinyl acetate copolymer, designed to be self-fitted by boiling and molding to individual teeth. It is indicated for protection against bruxism or night-time teeth grinding in adults 18 and older, intended to reduce tooth damage and associated grinding noise.
The device is a flexible, fully occlusive, boil-and-fit dental guard that keeps upper and lower teeth separated during sleep. It is offered in two sizes (small and large) for optimal fit, manufactured via injection molding, and is non-sterile and multi-use. The material contact and design are identical to the predicate device.
ANSI/ADA No. 99:2001 (reaffirmed 2023) for hardness, tear strength, and water adsorption testing. ISO 10993-1 for biocompatibility evaluation and risk management, and ISO 7405 for dentistry biocompatibility assessment of medical devices.
ClenchNoMore has the same intended use, indications, technological characteristics, materials, design, and manufacturing method as the predicate device (K231865). Bench testing confirms it meets ANSI/ADA physical property requirements, and biocompatibility testing shows it is non-toxic and non-sensitizing. Minor dimensional differences and the addition of a small size do not raise safety or effectiveness concerns and do not affect substantial equivalence.
View the full FDA submission: accessdata.fda.gov