FDA Registration
Active
🇺🇸 United States
ENCORE LABORATORY
Reg #: 3020749939
·
FEI: 3020749939
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- ENCORE LABORATORY
- Registration Number
- 3020749939
- FEI Number
- 3020749939
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1520 BROOKHOLLOW DR, STE 38
- City
- Santa Ana
- State
- CA
- ZIP
- 92705
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251926
Owner / Operator
- Firm Name
- enCore Laboratory
- Operator Number
- 10083076
- Address
- 1520 BROOKHOLLOW DR, STE 38
- City
- Santa Ana
- State
- CA
- Postal Code
- 92705
- Country
- US
- Correspondent
- Ben Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter | SHI | Class 2 | Dental | No | 2026-03-23 |
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2026-01-06 |
| Material, Impression | ELW | Class 2 | Dental | No | 2025-12-31 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2024-10-23 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2021-10-24 |
Proprietary Names
enCore Impression Material
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device