Duns Number:113170088
Device Description: Reliance Bonding Resins are intended for use in direct and indirect bonding of orthodontic Reliance Bonding Resins are intended for use in direct and indirect bonding of orthodontic brackets and appliances. 20g bottle Sealant resin A with fluoride.
Catalog Number
S20AF
Brand Name
Bonding Resin
Version/Model Number
S20AF
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K894565
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
e9d2d460-3e6a-4400-84f2-03ea1156dbf5
Public Version Date
July 06, 2018
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 |