FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
K Number: K252485
·
Decision Apr 10, 2026
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
44
Applicant Total
1
Review Days
246
Basic Information
- Device Name
- ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
- K Number
- K252485
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 1987 Media Limited
- Date Received
- August 7, 2025
- Decision Date
- April 10, 2026
- Product Code
- OBR
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBR | Mouthguard, Over-The-Counter | FDA unclassified | Unknown |
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