Duns Number:113170088
Device Description: Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed,deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth.This is a Unidose dispensing system. Single unidose capsule
Catalog Number
UAPSAM
Brand Name
Assure Plus
Version/Model Number
UAPSAM
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
Yes
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
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
97edb3c4-3f8e-47ba-8288-c8e106b0245e
Public Version Date
May 27, 2020
Public Version Number
1
DI Record Publish Date
May 19, 2020
Package DI Number
D798UAPSAM1
Quantity per Package
50
Contains DI Package
D798UAPSAM0
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |