Duns Number:695009476
Device Description: DESCRIPTIONThis is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to DESCRIPTIONThis is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside the mouth. There are two sizes available for the ATOZ key. INDICATION FOR USEThis is a product to expand the ATOZ expander.TRADE NAMEATOZ KeyMODEL NUMBERLonger key (MK Key-L), Shorter key (MK Key-S)
Catalog Number
-
Brand Name
ATOZ Key
Version/Model Number
MK Key-L and MK Key-S
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
DYJ
Product Code Name
Retainer, Screw Expansion, Orthodontic
Public Device Record Key
ef6b1e58-b5c0-44ea-a10a-be77c2497fe3
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 |