Duns Number:898067533
Device Description: Suppra Flow is a light-curing composite resin used for the restoration of slightly invasiv Suppra Flow is a light-curing composite resin used for the restoration of slightly invasive preparations, pit and fissure sealant, base/lining underneath direct restorations, in tunnel-type preparations, radiopaque lining of cavities, repairs of enamel defects, restorations of primary teeth, repairs in composite resin, bonding of tooth fragments, class I, III and V restorations, non-carious cervical lesions.
Catalog Number
4000055510
Brand Name
Suppra Flow
Version/Model Number
OA3.5 2g
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
2d12a7b2-517f-48b5-b84a-d4e779b13495
Public Version Date
October 11, 2021
Public Version Number
1
DI Record Publish Date
October 01, 2021
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |