Duns Number:324331826
Device Description: Device Name: Curasan OSSEOLIVE® DENTALlndications for Use:OSSEOLIVE® DENTAL is indicated f Device Name: Curasan OSSEOLIVE® DENTALlndications for Use:OSSEOLIVE® DENTAL is indicated for applications in oral andmaxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled(artificial or degenerative) bone defects, e.g.:- Defects after the extirpation of bone cysts- Augmentation of an atrophied alveolar ridge- Sinus lift or sinus floor elevation (subantral augmentation)- Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects- Defects after operative removal of retained teeth or corrective osteotomies
Catalog Number
5 x 0.5 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,K111105
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
3f509c20-614c-441b-b59a-946e61b2c5ac
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 |