| Primary Device ID | EDMG1712660 |
| NIH Device Record Key | 1e81605d-494a-44ee-a7bd-f6af1f66d2cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LuxaPrint Tray |
| Version Model Number | 171266 |
| Catalog Number | 171266 |
| Company DUNS | 320744915 |
| Company Name | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 201-894-5505 |
| kgamarello@dmg-america.com |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG1712660 [Primary] |
| HIBCC | EDMG1712661 [Package] Package: [1 Units] In Commercial Distribution |
| EBH | Material, Impression Tray, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-08 |
| Device Publish Date | 2020-03-31 |
| EDMG1712051 | (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ |
| EDMG1712041 | (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ |
| EDMG1712660 | (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ |