FDA UDI
In Commercial Distribution
🇺🇸 United States
CamX Spectra Interchangeable Head
DI: E247J27121
·
Model: J2712
·
DÜRR DENTAL SE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CamX Spectra Interchangeable Head
- Primary DI
- E247J27121
- Version / Model
- J2712
- Company Name
- DÜRR DENTAL SE
- Labeler DUNS
- 315563684
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-04
- Public Version
- 1
- Public Version Date
- 2022-03-14
- Public Version Status
- New
- Public Device Record Key
- ec6874ac-c38f-4bbc-aeca-19cf2c3350bf
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| NBL | Laser, Fluorescence Caries Detection | Dental | 872.1745 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63672 | Intraoral camera | An electro-optical device designed for image and/or video capture of the teeth and other intraoral anatomy, to assist with the diagnosis/management of dental/intraoral conditions (e.g., caries, plaque, calculus). It may be provided with specialized camera heads for specific types of examination (e.g., acquiring high resolution pictures/videos, emitting violet or infrared light), as well as camera holders and cables; it connects to an off-the-shelf computer (not included) for the power/processing/display. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E247J27121 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150672 | 000 |