SHI · Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Dental · 21 CFR 872.3660 · Class 2
Overview
| Product Code | SHI |
|---|---|
| Device Name | Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter |
| Regulation | 21 CFR 872.3660 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Classification Rationale
Class II (Special Controls).
Special Controls
*Classification.* Class II (Special Controls).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251926 | enCore Impression Material | Encore Guards | Mar 17, 2026 | SESE |
| K251724 | Remi Impression Material | Grindguard, Inc. | Feb 25, 2026 | SESE |
Top Applicants
- Grindguard, Inc. — 1 clearance
- Encore Guards — 1 clearance
