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Mouthguard, Over-The-Counter

FDA product code OBR · 44 cleared devices

Class U Unknown
Review panel
DE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2006-12-19 – 2026-09-16

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

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