Duns Number:001006089
Device Description: 6 ML EACH DENTASTIC ADHESIVE PRIMER PARTS A,B,C6 ML EACH UNFILLED RESIN BONDING AGENT PART 6 ML EACH DENTASTIC ADHESIVE PRIMER PARTS A,B,C6 ML EACH UNFILLED RESIN BONDING AGENT PARTS 1 AND 25 ML ETCH ALL, 10% PHOSPHORIC ACID ETCH GEL
Catalog Number
-
Brand Name
DenTASTIC® - Refill Kit
Version/Model Number
DASC1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2020
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
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
e95a1469-9152-4ca1-8c87-a0bf8136b6aa
Public Version Date
January 01, 2020
Public Version Number
4
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 |