Duns Number:113170088
Device Description: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brack Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Rely•a•Bond® is a No Mix Bonding System that sets on contact. Unlike powder/liquid and paste/paste systems, no mixing is required. Therefore, the operator controls the set time and reduces product waste. Kit contains 14g Adhesive Paste (tips), 16g Primer, etchant (liquid or gel) 9g, mixing pad, spatulas and brushes.
Catalog Number
RTF
Brand Name
Rely.a.Bond
Version/Model Number
RTF
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
41312a66-ed38-46c2-b441-b75188140da0
Public Version Date
July 24, 2020
Public Version Number
3
DI Record Publish Date
August 01, 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 |