FDA UDI
In Commercial Distribution
🇺🇸 United States
DEXcam4 HD
DI: D090101289070
·
Model: 1.012.8907
·
Dental Imaging Technologies Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DEXcam4 HD
- Primary DI
- D090101289070
- Version / Model
- 1.012.8907
- Company Name
- Dental Imaging Technologies Corporation
- Labeler DUNS
- 800111106
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-11
- Public Version
- 1
- Public Version Date
- 2025-12-19
- Public Version Status
- New
- Public Device Record Key
- b680f128-527a-4dfe-8f9d-8abb9c25f333
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58857 | Multi-purpose digital medical camera | An electrically-powered, hand-held digital electro-optical device designed to capture video or still image data for multiple medical applications (e.g., ophthalmoscopic, otoscopic, and dermatoscopic) using dedicated interchangeable lenses/attachments. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It may include a user display screen for visualization before image capture, and sometimes a docking cradle for battery recharging and connection to a personal computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D090101289030 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | D090101289070 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040691 | 000 |