Duns Number:320744915
Device Description: Light-curing bonding agent for use with phosphoric acid-based etching gel. One-push bondin Light-curing bonding agent for use with phosphoric acid-based etching gel. One-push bonding. Content: 60 SilvR dose @ 0.12 ml bond, 1 syringe @ 2 ml DMG Etching Gel, accessories.
Catalog Number
213320
Brand Name
TECO
Version/Model Number
213320
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
K063444,K131248
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
79af4c3e-91bf-4572-9c45-4b8e67d577e5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |