Duns Number:695009476
Device Description: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.Th The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
Catalog Number
-
Brand Name
ATOZ Mini-Screw
Version/Model Number
MKS-1616
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K210559
Product Code
OAT
Product Code Name
Implant, Endosseous, Orthodontic
Public Device Record Key
c22041fc-7b44-4a1f-85ca-0d673a2aac20
Public Version Date
March 14, 2022
Public Version Number
1
DI Record Publish Date
March 04, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |