Duns Number:316133664
Device Description: Flowable, highly viscous, highly radiopaque, light-curing nanohybrid composites for restor Flowable, highly viscous, highly radiopaque, light-curing nanohybrid composites for restoring small class I-III cavities, and also class V cavities. Is used in dentistry.
Catalog Number
75070
Brand Name
Micro Esthetic flow viscous A2
Version/Model Number
75070
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
K151399
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
6ba78164-8378-411c-a176-75300387e6c1
Public Version Date
June 30, 2020
Public Version Number
1
DI Record Publish Date
June 22, 2020
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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |