Duns Number:320744915
Device Description: Infiltration Concept. Resin Infiltration - Smooth Surface. Refill etching gel Icon-Etch. C Infiltration Concept. Resin Infiltration - Smooth Surface. Refill etching gel Icon-Etch. Content: 3 syringes Icon-Etch @ 0.45 ml, accessories.
Catalog Number
220385
Brand Name
Icon-Etch Refill
Version/Model Number
220385
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
-
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
K100062,K100062
Product Code
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
88da731d-1c42-4bc2-8a48-1bec378712f4
Public Version Date
July 09, 2019
Public Version Number
1
DI Record Publish Date
July 01, 2019
Package DI Number
EDMG2203851
Quantity per Package
3
Contains DI Package
EDMG2203850
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |