Duns Number:124763728
Device Description: Devices are used in dental implant applications for oral rehabilitation of edentulous and Devices are used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for restoration.
Catalog Number
-
Brand Name
Natural Profile Healing Abutment 5.0mm x 3.0mm, RP, Biomain, Ti
Version/Model Number
904907
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 09, 2021
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
K892124
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
39c4a03e-d406-492a-b5c4-7577ea495fc6
Public Version Date
August 10, 2021
Public Version Number
7
DI Record Publish Date
October 11, 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 |