| Primary Device ID | EDMG1712041 |
| NIH Device Record Key | 06d33f3f-c5e8-4ceb-b00b-874d58a875a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LuxaPrint Tray |
| Version Model Number | 171204 |
| Catalog Number | 171204 |
| 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 |
| eanagnostos@dmg-america.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG1712040 [Primary] |
| HIBCC | EDMG1712041 [Package] Contains: EDMG1712040 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 | 2019-07-02 |
| Device Publish Date | 2019-06-24 |
| 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/ |