| Primary Device ID | E21713780US1 |
| NIH Device Record Key | 54fab8d3-f2d1-43f6-9586-c662e295dca3 |
| Commercial Distribution Discontinuation | 2017-01-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Visalys Temp A1 USA Normal pack |
| Version Model Number | 13780US |
| Catalog Number | 13780US |
| 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 | E21713780US1 [Primary] |
| EBG | Crown And Bridge, Temporary, Resin |
| 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 | 2016-09-15 |
| E217177501 - Multi Tray | 2025-08-29 Multi Tray (Posterior) |
| E217177521 - Multi Tray | 2025-08-29 Multi Tray (Anterior) |
| E217177531 - Multi Tray | 2025-08-29 Multi Tray (Quandrant) |
| E217119231 - Futar | 2025-08-22 Futar Easy Normal pack |
| E217119241 - Futar | 2025-08-22 Futar Easy Fast Normal pack |
| E217172261 - Mixing Tips | 2025-08-22 Mixing tips, grey, 50 tips |
| E21711928111 - Futar | 2025-08-15 Futar Clear Fast Normal pack |
| E217220111 - Mixing Tips | 2025-08-15 Mixing tips, red, ø 4.0 mm 8 tips |