Duns Number:811180298
Device Description: Acrylic Temporary Resin for dental use, Tone A1. Content: 1 Cartridge, with 76 g + 10 mixi Acrylic Temporary Resin for dental use, Tone A1. Content: 1 Cartridge, with 76 g + 10 mixing tips.
Catalog Number
-
Brand Name
Nic Tone, MDC Dental
Version/Model Number
Bisacryl
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
4c4e5017-750f-41e0-aa41-6cb97b3ef5a4
Public Version Date
September 23, 2022
Public Version Number
3
DI Record Publish Date
July 26, 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 |