Duns Number:480055352
Device Description: Bone Level Mini Fixture Driver Ratchet Long Implant system for the support of dental prost Bone Level Mini Fixture Driver Ratchet Long Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses.
Catalog Number
S-BMFDRL
Brand Name
Implantswiss
Version/Model Number
S-BMFDRL
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
-
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
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
85b0e4b9-f53d-454e-8cf9-51b9ebc2403f
Public Version Date
May 19, 2021
Public Version Number
2
DI Record Publish Date
April 30, 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 |