Duns Number:439240722
Device Description: REUSABLE and STERILIZABLE device designed to remove a broken prosthetic screw from the ins REUSABLE and STERILIZABLE device designed to remove a broken prosthetic screw from the inside of a dental implant.
Catalog Number
680AOA
Brand Name
INVASIVE ACCESSORIES AND INSTRUMENTS
Version/Model Number
ESTRATTORE IMP. ASTRA ø 3,5-4 Acqua
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
-
Product Code
DZA
Product Code Name
Drill, Dental, Intraoral
Public Device Record Key
f1c997e5-43f2-48c3-a0a2-f443e7155dde
Public Version Date
July 20, 2021
Public Version Number
1
DI Record Publish Date
July 12, 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 | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |