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.
2
Total
2
Cleared
267d
Avg days
2026
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter Devices (Product Code SHI)
2 devices
Cleared
Mar 17, 2026
enCore Impression Material
Encore Guards
Dental
267d
Cleared
Feb 25, 2026
Remi Impression Material
Grindguard, Inc.
Dental
266d
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.