FDA Registration
Active
🇺🇸 United States
OP 3D Vision V17
Reg #: 3021551875
·
FEI: 3021551875
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Dental Imaging Technologies Corporation
- Registration Number
- 3021551875
- FEI Number
- 3021551875
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 450 Commerce Drive
- City
- Quakertown
- State
- PA
- ZIP
- 18951
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162085
Owner / Operator
- Firm Name
- Dental Imaging Technologies Corporation
- Operator Number
- 9007915
- Address
- 450 Commerce Drive, --
- City
- Quakertown
- State
- PA
- Postal Code
- 18951
- Country
- US
- Correspondent
- Erika Martin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2017-06-12 |
Proprietary Names
OP 3D Vision V17
i-CAT FLX V8
i-CAT FLX V17
OP 3D Vision V10
OP 3D Vision V8
i-CAT FLX V10
i-CAT FLX V-Series
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198