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. High spirits in 3D. Content: 1 Bottle @ 200 g
Catalog Number
171260
Brand Name
LuxaPrint Ortho Plus 405
Version/Model Number
171260
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
DYT
Product Code Name
Maintainer, Space Preformed, Orthodontic
Public Device Record Key
116e2020-42bc-4df2-aa15-8fe8e6950226
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
March 31, 2020
Package DI Number
EDMG1712601
Quantity per Package
1
Contains DI Package
EDMG1712600
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 |