Duns Number:124763728
Device Description: ERA abutments provide a resilient attachment with universal hinge movement. Available as ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
Catalog Number
-
Brand Name
ERA Implant Abutment Std 0 Deg, 2mm Cuff (AE)
Version/Model Number
904823
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K914764
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
271158d4-db8a-44f9-bbeb-4e669e0e3cef
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 29, 2020
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |