Duns Number:324331826
Device Description: Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor
Catalog Number
1x1cc
Brand Name
IngeniOS ß-TCP Bioactiv Synthetic Bone Particles
Version/Model Number
1-2mm
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
K103709
Product Code
LPK
Product Code Name
Bone Grafting Material, For Dental Bone Repair
Public Device Record Key
bc1eb380-e889-4e9c-a97c-c42bf22db0c3
Public Version Date
November 07, 2019
Public Version Number
1
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |