Duns Number:342962296
Device Description: (Meth) acrylate-based light-curing resin for the fabrication of custom impression trays. F (Meth) acrylate-based light-curing resin for the fabrication of custom impression trays. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 2 kg
Catalog Number
171258
Brand Name
LuxaPrint Tray
Version/Model Number
171258
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
ed3669f3-6736-4634-84ba-b867b1dd9882
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
D9821712581
Quantity per Package
1
Contains DI Package
D9821712580
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 |