Duns Number:024222105
Device Description: Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Catalog Number
OST413
Brand Name
Osteo-i Synthetic Biphasic Dental Bone Graft Granules
Version/Model Number
03-030-01-SAS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 07, 2019
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
-
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
e01d88aa-6b01-4fca-acec-b434684d01e3
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
October 30, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |