FDA UDI
In Commercial Distribution
🇺🇸 United States
Nobel Biocare®
DI: 07332747009125
·
Model: 15404
·
Nobel Biocare AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nobel Biocare®
- Primary DI
- 07332747009125
- Version / Model
- 15404
- Catalog Number
- 15404
- Company Name
- Nobel Biocare AB
- Labeler DUNS
- 353939929
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-22
- Public Version
- 2
- Public Version Date
- 2023-07-24
- Public Version Status
- Update
- Public Device Record Key
- 9768255e-128d-4adf-9978-a7cee36ed5f9
Device Description
Finished Surgical Template 2-4 implants
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant
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 |
|---|---|---|---|---|
| 57949 | Dental guided surgery reference plate | A non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07332747009125 | GS1 |
Customer Contacts
- Phone
- +1(800)322-5001
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry