SHI

Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

Product code

SHI

Device name

Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

Device class

Class 2

21 CFR

21 CFR 872.3660

Medical specialty

Dental

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-03-17.

2 summaries are archived here for direct download.