Duns Number:113170088
Device Description: The aligner attachment kit is intended for use in the creation of molds for thermoplastic The aligner attachment kit is intended for use in the creation of molds for thermoplastic alligners.The Oval Attachment Form can be used for the retention of the thermoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown.The Rectangle Attachment Form can be used for individual tooth movement and for extrusion of teeth.The Assure Bonding Resin included will bond to all intraoral surfaces without additional primers.L.C.R. Light Cure Paste cures smooth as glass for patient comfort. It has a very high Barcol Hardness for long term durability.
Catalog Number
A2
Brand Name
A2
Version/Model Number
A2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2017
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
-
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
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
9a1f6d38-02c2-4840-b76a-ae3356b3b5b7
Public Version Date
March 29, 2018
Public Version Number
2
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 |