DeviceClearance

Product code SHI— Dental

Remi Impression Material

Classification name
Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Device class
Class 2
Regulation
21 CFR 872.3660
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SHI under 21 CFR 872.3660, via openFDA

Market context for product code SHI

FDA has cleared 2 devices under product code SHI, all in 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHI

Recent clearances under product code SHI

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