FDA Registration
Active
🇺🇸 United States
ENDO DIRECT, LLC
Reg #: 3027344570
·
FEI: 3027344570
·
Expires 2026
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ENDO DIRECT, LLC
- Registration Number
- 3027344570
- FEI Number
- 3027344570
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 24 Abeel Rd
- City
- Monroe
- State
- NJ
- ZIP
- 08831
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193409
Owner / Operator
- Firm Name
- Endo Direct, LLC
- Operator Number
- 10088054
- Address
- 24 Abeel Rd
- City
- Monroe
- State
- NJ
- Postal Code
- 08831
- Country
- US
- Correspondent
- A. Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2023-05-22 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2023-05-22 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2025-12-06 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2023-05-22 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2025-12-06 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2023-05-22 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2023-05-22 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2023-05-22 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2023-05-18 |
Proprietary Names
EndoCeramic Root Repair Material
Establishment Types
Repack or Relabel Medical Device