Duns Number:113170088
Device Description: Rescue is intended as an aid for bonding to enamel, composite, porcelain, plastic and meta Rescue is intended as an aid for bonding to enamel, composite, porcelain, plastic and metal surfaces. Kit contains: 1 X 6ml Assure Universal Bonding Resin, 1 X 8cc Porcelain Conditioner, 1 X 10cc Plastic Conditioner, 1 X 7g Porcelain Etchant, 1 X 3cc Barrier Gel
Catalog Number
R
Brand Name
Rescue
Version/Model Number
R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 2017
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
676ee7ae-9181-41a8-b7de-efc84ab6e037
Public Version Date
October 29, 2018
Public Version Number
4
DI Record Publish Date
August 15, 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 |