Dental Device Guide
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Prosthetic devices · 21 CFR 872 Subpart D

Over-the-Counter Impression Material for Fabrication of Patient-Matched Mouthguards

An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards.

FDA codeSHIClass221 CFR872.3660Pathway510(k)
Companies listing it
33 makers
Brands and models
3
510(k) clearances
44 in five years
FDA name
Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
2026: 419801990200020102020

510(k) clearances per year, 1976–2026

Companies that list SHI

3 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Sleepcare, LLCUnited StatesMakerDaybreak Impression Material OTC12026
GrindGuard IncUnited StatesMakerRemi Impression Material12026
enCore LaboratoryUnited StatesMakerenCore Impression Material——

510(k) clearances

Decided510(k)DeviceApplicant
20 Oct 2026K262421Daybreak Impression MaterialSleepcare, LLC
16 Sep 2026K261888ClearClub Impression MaterialClearClub
17 Mar 2026K251926enCore Impression MaterialEncore Guards
25 Feb 2026K251724Remi Impression MaterialGrindGuard Inc

Official records: FDA product classification for SHI · 21 CFR 872.3660.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026