Duns Number:320744915
Device Description: Temporary crown and bridge material automix system; bis-acrylic composite. Naturally esthe Temporary crown and bridge material automix system; bis-acrylic composite. Naturally esthetic. Content: 1 cartridge @ 76g paste, accessories. Color: BL
Catalog Number
110589
Brand Name
Luxatemp® Fluorescence
Version/Model Number
110589
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
K013674,K013674,K013674
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
7443e4c4-ceac-45a7-ade1-acd4844a923e
Public Version Date
October 29, 2021
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
EDMG1105898
Quantity per Package
12
Contains DI Package
EDMG1105891
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 |