Duns Number:021228671
Device Description: Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astr Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astra Tech Implant System EV 3.0
Catalog Number
70-1176-COM0278
Brand Name
Inclusive
Version/Model Number
70-1176-COM0278
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
K191222
Product Code
NHA
Product Code Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Public Device Record Key
bc4ec350-0f50-4c54-b9ae-9f6397b7c779
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
August 23, 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 |
|---|---|---|
| 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 |