Duns Number:324331826
Device Description: Device Name: Curasan OSSEOLIVE® DENTALlndications for Use:OSSEOLIVE® DENTAL is indicated f
Catalog Number
1 x 2.0 cc
Brand Name
Osseolive Dental
Version/Model Number
1000-2000µm
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111105
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
63fc1bb0-3c33-4607-9801-d7e47de32f57
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 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 |