Duns Number:124763728
Device Description: Designed for both transitional and long-term denture stabilization, the ERA Micro Dental I
Catalog Number
-
Brand Name
ERA 2.2MM ANGLE IMP MICRO HEAD 15X2MM ACID ETCH, Ti
Version/Model Number
923298
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 20, 2019
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
K092434
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
74e7424b-d613-4803-ae6a-ac3abfbd9ed2
Public Version Date
May 27, 2020
Public Version Number
6
DI Record Publish Date
March 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 | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 1346 |