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 @ 500 g
Catalog Number
171212
Brand Name
LuxaPrint Ortho Plus 405
Version/Model Number
171212
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 24, 2019
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
DYT
Product Code Name
Maintainer, Space Preformed, Orthodontic
Public Device Record Key
0657141d-7cf8-416f-9681-d56a7967304a
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
June 24, 2019
Package DI Number
EDMG1712121
Quantity per Package
1
Contains DI Package
EDMG1712120
Package Discontinue Date
June 24, 2019
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 |