Duns Number:324331826
Device Description: Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes
Catalog Number
1 x 2.0 cc
Brand Name
Osbone Dental
Version/Model Number
250-1000µm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102872
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
1a772f58-3955-452c-a923-36ba70d4ca13
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 11, 2017
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. | 58 |