# Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
> **Product code: SHI** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3660
## Classification
- **FDA Product Code:** SHI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.3660
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SHI)
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