Duns Number:320744915
Device Description: Automix core build-up composite. Core buildups and post cementation with 5 stars. Content: Automix core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @ 50 g paste, Accessories. Color: A3
Catalog Number
212033
Brand Name
LuxaCore® Automix Dual Intro Kit
Version/Model Number
212033
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
K012307,K012307
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
c48c5854-1dba-4286-a5a7-7bcd102d66f4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG2120331
Quantity per Package
1
Contains DI Package
EDMG2120330
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |