Duns Number:199354556
Device Description: Sonic-Activated, Single-Fill Composite; Intro Kit
Catalog Number
-
Brand Name
SonicFill 3
Version/Model Number
36710
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
b037fb3b-0156-49c5-938e-495e6a09fee6
Public Version Date
February 15, 2021
Public Version Number
3
DI Record Publish Date
July 27, 2018
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 | 98 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |
| U | Unclassified | 5 |