| Primary Device ID | E21713790US1 |
| NIH Device Record Key | 9661b1d4-2301-40fe-94b2-dda32255f5bc |
| Commercial Distribution Discontinuation | 2017-01-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Visalys Temp |
| Version Model Number | 13790US |
| Catalog Number | 13790US |
| 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 | E21713790US1 [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 |
| E217137981 | Visalys Temp A3 Superbulk |
| E217137951 | Visalys Temp A3 Bonus pack |
| E217137941 | Visalys Temp A2 Bonus pack |
| E21713790US1 | Visalys Temp A3,5 USA Normal pack |
| E21713788US1 | Visalys Temp BL USA Normal pack |
| E217137851 | Visalys Temp A3 Intro pack |
| E21713784US1 | Visalys Temp B1 USA Normal pack |
| E217137831 | Visalys Temp A3 Sample |
| E21713782US1 | Visalys Temp A3 USA Normal pack |
| E217137821 | Visalys Temp A3 Normal pack |
| E21713781US1 | Visalys Temp A2 USA Normal pack |
| E217137811 | Visalys Temp A2 Normal pack |
| E217137801 | Visalys Temp A1 Normal pack |