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., Encore Guards and ClearClub.
3
Total
3
Cleared
212d
Avg days
2026
Since
Growing category -
3 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)
3 devices
Cleared
Sep 16, 2026
ClearClub Impression Material
ClearClub
Dental
103d
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
3 total 510(k) submissions under product code SHI since 2026, with 3 receiving FDA clearance (average review time: 212 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.