Duns Number:689370711
Device Description: Nano-hybrid Flowable composite resin for posterior and anterior restorations.
Catalog Number
101-0802
Brand Name
EsFlow A2 Syringe
Version/Model Number
101-0802
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
b6595ff7-da51-4931-b0ec-97f549a1d23f
Public Version Date
January 26, 2021
Public Version Number
7
DI Record Publish Date
February 20, 2017
Package DI Number
20210305170597
Quantity per Package
420
Contains DI Package
08809262954722
Package Discontinue Date
September 30, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |