FDA Registration
Active
🇺🇸 United States
OVERJET
Reg #: 3019544554
·
FEI: 3019544554
·
Expires 2026
Products
4
Proprietary Names
10
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OVERJET
- Registration Number
- 3019544554
- FEI Number
- 3019544554
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 200 State St Ste 1220
- City
- Boston
- State
- MA
- ZIP
- 02109
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222746
Owner / Operator
- Firm Name
- Overjet
- Operator Number
- 10082112
- Address
- 200 State St Ste 1220
- City
- Boston
- State
- MA
- Postal Code
- 02109
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Medical Image | MYN | Class 2 | Radiology | No | 2023-10-19 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-12-09 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-11-04 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2024-02-15 |
Proprietary Names
Overjet Caries Assist
Overjet CBCT Assist
Overjet Image Enhancement Assist
Overjet Dental Assist
Overjet Periapical Radiolucency Assist
Overjet Caries Assist-Pediatric
Overjet DI System
Overjet Calculus Assist
Overjet Iris Intelligent Imaging System
Overjet Charting Assist
Establishment Types
Manufacture Medical Device