Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3660](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3660) → SHI — Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

# SHI · Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

_Dental · 21 CFR 872.3660 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/SHI

## Overview

- **Product Code:** SHI
- **Device Name:** Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
- **Regulation:** [21 CFR 872.3660](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3660)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## 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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/SHI/K251926.md) | enCore Impression Material | Encore Guards | Mar 17, 2026 | SESE |
| [K251724](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/SHI/K251724.md) | Remi Impression Material | Grindguard, Inc. | Feb 25, 2026 | SESE |

## Top Applicants

- Grindguard, Inc. — 1 clearance
- Encore Guards — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/SHI](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/SHI)

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