Duns Number:001006089
Device Description: 2-PASTE RESIN-IONOMER ORTHO BAND CEMENT, DUAL CURE, FLUORIDE RELEASINGKIT: 22.8 gm base, 2 2-PASTE RESIN-IONOMER ORTHO BAND CEMENT, DUAL CURE, FLUORIDE RELEASINGKIT: 22.8 gm base, 25.2 gm catalyst, mixing pad, spatulas
Catalog Number
-
Brand Name
BAND-RITE™, Ortho-Choice™
Version/Model Number
OCBR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2016
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
3eb8f06f-97ea-4c7d-909d-47c23cbd3a76
Public Version Date
November 26, 2019
Public Version Number
3
DI Record Publish Date
July 21, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |