FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Owl Night Guard
K Number: K253641
·
Decision Feb 26, 2026
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
44
Applicant Total
1
Review Days
99
Basic Information
- Device Name
- Owl Night Guard
- K Number
- K253641
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Owl Dental Lab, Inc.
- Date Received
- November 19, 2025
- Decision Date
- February 26, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBR), ordered by most recent decision date.
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
FDA 510(k)
FDA Unclassified
·Unknown
enCore Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
Remi Custom Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
Dentemp Pro-Comfort Dental Guard
FDA 510(k)
FDA Unclassified
·Unknown
Anti Grinding Guard
FDA 510(k)
FDA Unclassified
·Unknown
Goyo Mouthpiece S
FDA 510(k)
FDA Unclassified
·Unknown