Duns Number:342962296
Device Description: (Meth) acrylate-based light-curing resin for the fabrication of surgical guides and splint (Meth) acrylate-based light-curing resin for the fabrication of surgical guides and splints. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 1 kg
Catalog Number
171207
Brand Name
LuxaPrint Ortho 385
Version/Model Number
171207
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
-
Product Code
DYT
Product Code Name
Maintainer, Space Preformed, Orthodontic
Public Device Record Key
5eda6943-de8a-4853-a9e5-193fb87adde1
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
D9821712071
Quantity per Package
1
Contains DI Package
D9821712070
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |