FDA UDI
In Commercial Distribution
🇺🇸 United States
Neodent XenoGraft
DI: 08809186541954
·
Model: I1-0210-025
·
Nibec Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neodent XenoGraft
- Primary DI
- 08809186541954
- Version / Model
- I1-0210-025
- Company Name
- Nibec Co., Ltd.
- Labeler DUNS
- 687796909
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- a7fb1101-ccf0-458e-8987-9a10bb8c44b3
Device Description
The Neodent XenoGraft bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The Neodent XenoGraft contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of Neodent XenoGraft is effective for the regeneration of new bone around the grafted bone. The Neodent XenoGraft has good osteoconductivity to enhance new bone formation. The Neodent XenoGraft are supplied as cancellous (spongiosa) or cortical granules in single-use containers.
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47968 | Dental bone matrix implant, animal-derived | A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809186541954 | GS1 |
Customer Contacts
- Phone
- +827050068814
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113246 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.25 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius