FDA Registration
Active
🇺🇸 United States
OWL DENTAL
Reg #: 3030268763
·
FEI: 3030268763
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- OWL DENTAL
- Registration Number
- 3030268763
- FEI Number
- 3030268763
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 345 Estudillo Ave # 211
- City
- San Leandro
- State
- CA
- ZIP
- 94577
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133071
Owner / Operator
- Firm Name
- Owl Dental
- Operator Number
- 10095355
- Address
- 345 Estudillo Ave., 211
- City
- San Leandro
- State
- CA
- Postal Code
- 94577
- Country
- US
- Correspondent
- Jennifer Day
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2026-03-03 |
| Mouthguard, Migraine/Tension Headache | OCO | Class U | Unknown | No | 2026-03-03 |
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2026-03-03 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2026-03-03 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2026-03-03 |
Proprietary Names
Owl Impression Material
Owl Night Guard
Owl Impression Tray
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device