Duns Number:480055352
Device Description: Tissue level Fixture Hybrid SRA 4.8 x 8 mm "Implant system for the support of dental prost
Catalog Number
S-TFHR4808
Brand Name
Implantswiss
Version/Model Number
S-TFHR4808
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
4e08caca-0779-494e-ad0f-fced4c885d06
Public Version Date
April 09, 2021
Public Version Number
2
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 |