FDA Registration
Active
🇺🇸 United States
WYKLE RESEARCH, INC.
Reg #: 2020703
·
FEI: 2020703
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- WYKLE RESEARCH, INC.
- Registration Number
- 2020703
- FEI Number
- 2020703
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2222 EAST COLLEGE PARKWAY
- City
- CARSON CITY
- State
- NV
- ZIP
- 89706
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002808
Owner / Operator
- Firm Name
- WYKLE RESEARCH INC
- Operator Number
- 2020703
- Address
- 2222 EAST COLLEGE PARKWAY, --
- City
- Carson City
- State
- NV
- Postal Code
- 89706
- Country
- US
- Correspondent
- Andre Wallin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Capsule, Dental, Amalgam | DZS | Class 1 | Dental | No | 1992-11-19 |
| Alloy, Amalgam | EJJ | Class 2 | Dental | No | 2016-09-13 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 1992-11-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2016-06-27 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2023-04-18 |
| Dental Amalgam | OIV | Class 2 | Dental | No | 2016-08-31 |
Proprietary Names
Wykalloy
ANA 70
ANA 2000
linea tac 400c
Wykle wedges
Plaque Photo
Original D Powder, Tablets, and Capsules
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device