Duns Number:695009476
Device Description: PRODUCT SUMMARYThis is a bendable stainless steel wire which can be connected to the ATOZ PRODUCT SUMMARYThis is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement.TRADE NAMEATOZ Wire armMODEL NAMEMK Wire arm-1240INDICATION FOR USEThis can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement with bending the wire arm various shape according to the treatment plan.PRODUCT MATERIAL316L Stainless SteelCONSIST OF: MK-Wire arm-1240*4ea
Catalog Number
-
Brand Name
ATOZ-Tooth Connection Arms
Version/Model Number
MK-Wire arm-1240
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
DZC
Product Code Name
Wire, Orthodontic
Public Device Record Key
cdb65944-1dd3-4a61-9b86-63166e9e584b
Public Version Date
January 31, 2022
Public Version Number
1
DI Record Publish Date
January 22, 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 |