Duns Number:113170088
Device Description: A2 Oval Attachment Form can be used for the retention of themoplastic aligners and for hor A2 Oval Attachment Form can be used for the retention of themoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown.
Catalog Number
AO
Brand Name
A2
Version/Model Number
AO
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 09, 2020
Issuing Agency
In HIBCC
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
KXR
Product Code Name
Applicator, Resin
Public Device Record Key
2c97e97c-c75b-488b-b381-9c4e9d6d1c50
Public Version Date
July 10, 2020
Public Version Number
3
DI Record Publish Date
July 25, 2016
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |