| Primary Device ID | EDMG2133681 |
| NIH Device Record Key | 3d5296f7-3792-4c8a-8f60-548c8ba74464 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PermaCem 2.0 Self-Adhesive |
| Version Model Number | 213368 |
| Catalog Number | 213368 |
| Company DUNS | 320744915 |
| Company Name | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG2133680 [Primary] |
| HIBCC | EDMG2133681 [Package] Contains: EDMG2133680 Package: [1 Units] In Commercial Distribution |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| EDMG2133681 | Self-adhesive dual-cure composite cement. Inseparable. Zirconia and PermaCem 2.0. Content: 1 syr |
| EDMG2133671 | Self-adhesive dual-cure composite cement. Inseparable. Zirconia and PermaCem 2.0. Content: 1 syr |
| EDMG2133661 | Self-adhesive dual-cure composite cement. Inseparable. Zirconia and PermaCem 2.0. Content: 1 syr |