Duns Number:044161695
Device Description: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceram
Catalog Number
HA90D10S
Brand Name
InRoad® Dental Synthetic Bone Graft
Version/Model Number
HA90D Small (0.3 – 1.0 mm) 1.0 cc
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K202675
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
a036ea5b-32c7-4af4-a02c-ced1a8cbdf4f
Public Version Date
June 02, 2022
Public Version Number
1
DI Record Publish Date
May 25, 2022
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. | 6 |