Duns Number:148312838
Device Description: Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary cr Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns and bridges with ease and convenience. The static mixing tip provides automatic mixing from the dual chambered cartridge to greatly reduce in-office procedure time. The Bix-acryl material is very durable, color stable, and water resistant. The greater flexibility facilitates deformation free removal of the material from the patient's mouth. Alpha-Crown® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 74g Cartridge (Shade A1), 10 Automix Tips
Catalog Number
113.0005.002
Brand Name
Alpha-Crown®
Version/Model Number
113.0005.002
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
-
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
K960122
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
fef34b1a-cc4f-42b4-bc77-2233ef5b59ab
Public Version Date
October 29, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |