Duns Number:811180298
Device Description: Tone A3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is Tone A3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used in the elaboration of all kinds of temporary dental Provisionals: inlays, onlays, veneers, bridges and partial or total crowns.It can be used as a filling / relining material for precast and temporary composite and metal crowns.
Catalog Number
-
Brand Name
MDC Dental
Version/Model Number
Bisacryl Nictone A3 Tone
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K991577
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
57e22c5f-97ad-4510-a6c3-8de203e43d4f
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
September 28, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |