Duns Number:113170088
Device Description: The Reliance Button Hook Aligner Attachments are intended for use in securing a Class II e The Reliance Button Hook Aligner Attachments are intended for use in securing a Class II elastic to a thermoplastic aligner or enamel surface.
Catalog Number
ABUT
Brand Name
A2
Version/Model Number
ABUT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
fc7a94fa-4b47-455a-9e51-89c8cb949ac8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 13, 2017
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 |