Duns Number:439240722
Device Description: Burs used to remove broken screws from the internal thread of the implant.
Catalog Number
680SPL325
Brand Name
INVASIVE ACCESSORIES AND INSTRUMENTS
Version/Model Number
ESTRATTORE IMP. SPLINE ø 3,25
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZA
Product Code Name
Drill, Dental, Intraoral
Public Device Record Key
10b69cd3-1cfe-40db-92dc-97af5bb3e5b7
Public Version Date
July 18, 2022
Public Version Number
1
DI Record Publish Date
July 08, 2022
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 | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |