| Primary Device ID | E217135921 |
| NIH Device Record Key | 6fc063c7-1b86-44ae-b921-644607f768fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visalys CemCore Try In Paste |
| Version Model Number | 13592 |
| Catalog Number | 13592 |
| Company DUNS | 316803246 |
| Company Name | Kettenbach GmbH & Co. KG |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E217135921 [Primary] |
| EBF | Material, Tooth Shade, 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 | 2019-12-03 |
| Device Publish Date | 2019-11-25 |
| E217135941 | Visalys CemCore Try In Paste Dark (A4) 1 x 1,4 ml + 5 Application tips |
| E217135931 | Visalys CemCore Try In Paste Opaque 1 x 1,4 ml + 5 Application tips |
| E217135921 | Visalys CemCore Try In Paste Universal (A2/A3) 1 x 1,4 ml + 5 Application tips |
| E21713592 | Visalys CemCore Try In Paste Universal (A2/A3) 1 x 1,4 ml + 5 Application tips |
| E217135911 | Visalys CemCore Try In Paste Bleach 1 x 1,4 ml + 5 Application tips |
| E217135901 | Visalys CemCore Try In Paste Translucent 1 x 1,4 ml + 5 Application tips |