Duns Number:324331826
Device Description: Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the fillin
Catalog Number
1 x 0.5 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
97e24523-2ec4-45bb-afe1-03f759da8690
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 |