Duns Number:131500998
Device Description: INTRAHEX O-Ball Abutment, Height 4mm, w/ O-Ring Assy
Catalog Number
IHBA4
Brand Name
IntraHex
Version/Model Number
IHBA4
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021322
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
efa4ba81-dc4b-440b-9fc8-73ad15efaed6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 08, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 329 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 918 |