Duns Number:124763728
Device Description: The ERA Implant Surgical Kit consists of various surgical tools such as drills, countersin The ERA Implant Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure.
Catalog Number
-
Brand Name
ERA Implant® Surgical Kit, Complete
Version/Model Number
905119
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 07, 2020
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
-
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
K041271
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
8e349f9e-346d-4a53-bb80-6797645be789
Public Version Date
August 10, 2020
Public Version Number
2
DI Record Publish Date
July 07, 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 |