Duns Number:687796909
Device Description: The Neodent XenoGraft bone grafting material is a sterile, porous bone mineral matrix prod 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.
Catalog Number
-
Brand Name
Neodent XenoGraft
Version/Model Number
I1-0210-025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113246
Product Code
NPM
Product Code Name
Bone Grafting Material, Animal Source
Public Device Record Key
a7fb1101-ccf0-458e-8987-9a10bb8c44b3
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 102 |