Duns Number:094146123
Device Description: Locator Abutment 4mm4mm Diameter6mm Height
Catalog Number
8955
Brand Name
TSI/ERI/Macro Locator Abutment
Version/Model Number
Locator Abutment 4mm
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
-
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
72947211-1647-4273-b82f-b039354b0861
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 08, 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 | 76 |
2 | A medical device with a moderate to high risk that requires special controls. | 348 |