FDA Product Code SHI: Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter
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.
Leading manufacturers include Grindguard, Inc. and Encore Guards.
FDA 510(k) Cleared Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter Devices (Product Code SHI)
About Product Code SHI - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SHI since 2026, with 2 receiving FDA clearance (average review time: 267 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SHI devices are reviewed by the Dental panel. Browse all Dental devices →