FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NobelDesign™
DI: 07332747125191
·
Model: 1.4
·
Nobel Biocare AB
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NobelDesign™
- Primary DI
- 07332747125191
- Version / Model
- 1.4
- Catalog Number
- 38412
- Company Name
- Nobel Biocare AB
- Labeler DUNS
- 353939929
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-07
- Public Version
- 7
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 611cb41f-87eb-4282-bed8-aba748084ec5
- Distribution End Date
- 2018-02-07
Device Description
NobelDesign 1.4 for Windows 64-bit
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34713 | Dental milling system, CAD/CAM, laboratory | An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for production of the actual device(s) for delivery and final fitting to the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07332747125191 | GS1 |
Customer Contacts
- Phone
- +1(800)322-5001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171466 | 000 |