FDA UDI
In Commercial Distribution
🇺🇸 United States
Primescan 2
DI: E27668558402
·
Model: 6855840
·
SIRONA Dental Systems GmbH
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
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Basic Information
- Brand Name
- Primescan 2
- Primary DI
- E27668558402
- Version / Model
- 6855840
- Catalog Number
- 6855840
- Company Name
- SIRONA Dental Systems GmbH
- Labeler DUNS
- 340306351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2025-08-20
- Public Version
- 2
- Public Version Date
- 2025-09-15
- Public Version Status
- Update
- Public Device Record Key
- b778507b-a9c0-48b2-9020-abfc46965a09
Device Description
Single use sleeve Primescan 2 Box
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | Dental | 872.3661 | 2 |
| NTK | Caries detector, laser light, transmission | Dental | 872.1745 | 2 |
| NBL | Laser, fluorescence caries detection | Dental | 872.1745 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63669 | Intraoral optical scanning system | An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | E27668127750 | HIBCC | ||||
| Primary | E27668558402 | HIBCC |
Customer Contacts
- Phone
- +4962511670
- [email protected]