← FDA Medical Device Classifications
Mouthguard, Over-The-Counter
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown