Duns Number:480055352
Device Description: Tissue level Wide Fixture Hybrid SRA 5.5 x 8 mm "Implant system for the support of dental Tissue level Wide Fixture Hybrid SRA 5.5 x 8 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Implant: The part of the system that is inserted in and connected to the jaw bone to allow for prosthesis superstructure fixation, which includes an abutment."
Catalog Number
S-TWFHR5508
Brand Name
Implantswiss
Version/Model Number
S-TWFHR5508
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
K181266
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
4b6f9697-6116-43dd-8bc1-54546ee05d2b
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
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 | 208 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |