Duns Number:324331826
Device Description: Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implant Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge
Catalog Number
1x0.5cc
Brand Name
IngeniOS HA
Version/Model Number
1-2mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 30, 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
K102872
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
ce77a8c0-e8b6-4cc2-9f5c-5b5cc4f5539c
Public Version Date
October 31, 2019
Public Version Number
4
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 |