FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NobelProcera®
DI: 07332747019339
·
Model: 35549
·
Nobel Biocare AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NobelProcera®
- Primary DI
- 07332747019339
- Version / Model
- 35549
- Catalog Number
- 35549
- Company Name
- Nobel Biocare AB
- Labeler DUNS
- 353939929
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-10
- Public Version
- 2
- Public Version Date
- 2023-11-13
- Public Version Status
- Update
- Public Device Record Key
- 42dcfa35-6bd8-4e91-9e9e-4846af48df6d
- Distribution End Date
- 2023-06-26
Device Description
NobelProcera Abutment Position Locator Bmk Syst WP
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
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, implant, dental, endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61640 | Dental implant abutment analog, laboratory | A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07332747019339 | GS1 |
Customer Contacts
- Phone
- +1(800)322-5001
- [email protected]