Duns Number:021228671
Device Description: Inclusive Angled Multi-Unit Abutment Screw compatible with: Hiossen HG System Mini
Catalog Number
70-1147-COM0080
Brand Name
Inclusive
Version/Model Number
70-1147-COM0080
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
K151375
Product Code
NHA
Product Code Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Public Device Record Key
0ad49ea1-bb78-4633-9c7d-7d37d1fb1dbb
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
October 07, 2016
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 | 510 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2971 |
| U | Unclassified | 2 |