FDA Registration
Active
🇺🇸 United States
Denterprise International, Inc.
Reg #: 1000113729
·
FEI: 1000113729
·
Expires 2026
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Denterprise International, Inc.
- Registration Number
- 1000113729
- FEI Number
- 1000113729
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 220 John Anderson Dr
- City
- Ormond Beach
- State
- FL
- ZIP
- 32176
- Country
- US
Owner / Operator
- Firm Name
- Denterprise International, Inc
- Operator Number
- 10034629
- Address
- 220 John Anderson Dr.
- City
- Ormond Beach
- State
- FL
- Postal Code
- 32176
- Country
- US
- Correspondent
- Claude Berthoin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intraoral Camera | QJK | Class 2 | Dental | No | 2022-10-17 |
Proprietary Names
EyeCam
TeliCam
EyeCam Intraoral Camera
iCam Intraoral Camera
iCam
Disposable Cover Sheaths for MD770, iCam, ProSys, EyeCam Intraoral Cameras
ProSys Intraoral Camera
MD770 Intraoral Camera
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device