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Mouthguard, Over-The-Counter

Mouthguard, Over-The-Counter is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Mouthguard, Over-The-Counter
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OBR

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Class U

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

Definition

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