# Mouthguard, Over-The-Counter
> **Product code: OBR** · Unclassified · Unknown · —
## Classification
- **FDA Product Code:** OBR
- **Device class:** Unclassified
- **Regulation:** —
- **Review panel:** DE
- **Medical specialty:** Unknown
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

## Market data
- **Cleared 510(k) submissions:** 45
- **Registered establishments:** 33
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OBR)
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