Duns Number:113170088
Device Description: Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appl Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces. Can also be used for forming button attachments. Bond Aligner is formulated to work with clear, thermoforming aligner plastics. It is not recommended for use with cloudy (Class C) thermoforming materials.Bond Aligner is a clear, light cure adhesive to adhere metal, ceramic or plastic attachments to a thermoplastic aligner.
Catalog Number
1 BA
Brand Name
Bond Aligner
Version/Model Number
1BA
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
-
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
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
fba33195-9a22-49b2-ae81-496dc4859ef0
Public Version Date
July 27, 2020
Public Version Number
1
DI Record Publish Date
July 17, 2020
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 |