Duns Number:320744915
Device Description: (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 200 g
Catalog Number
171266
Brand Name
LuxaPrint Tray
Version/Model Number
171266
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
-
Product Code
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
1e81605d-494a-44ee-a7bd-f6af1f66d2cc
Public Version Date
November 20, 2020
Public Version Number
2
DI Record Publish Date
March 31, 2020
Package DI Number
EDMG1712661
Quantity per Package
1
Contains DI Package
EDMG1712660
Package Discontinue Date
March 31, 2020
Package Status
Not 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 |