Duns Number:079280537
Device Description: 400 Series Wide Thread, Root Form Implant, 5.5mm Diameter x 10mm Length. Included with the 400 Series Wide Thread, Root Form Implant, 5.5mm Diameter x 10mm Length. Included with the implant is the matching, sterile packed, carrier and cover screw.
Catalog Number
-
Brand Name
Implant-One
Version/Model Number
IW4-5510-00
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
86eafd21-cc71-492f-ba2c-c65f4cb5b3fe
Public Version Date
June 16, 2022
Public Version Number
3
DI Record Publish Date
August 25, 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 | 185 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 449 |