Duns Number:320744915
Device Description: Infiltration Concept. Resin Infiltration - Proximal. Early arrest of caries - without dril Infiltration Concept. Resin Infiltration - Proximal. Early arrest of caries - without drilling. Content: 7 treatment units (each contains 1 syringe Icon-Etch @ 0.30 ml, 1 syringe Icon-Dry @0.45 ml, 1 syringe Icon-Infiltrant @ 0.45 ml), accessories.
Catalog Number
220401
Brand Name
Icon®
Version/Model Number
220401
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
K100062,K100062
Product Code
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
83927d7e-7edb-4e5c-9296-e19f4ea5d611
Public Version Date
May 14, 2019
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG2204011
Quantity per Package
7
Contains DI Package
EDMG2204010
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 |