| Primary Device ID | E217142041 |
| NIH Device Record Key | 2c023dd5-43da-40c7-bd19-0bec2e86fea5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Identium Adhesive |
| Version Model Number | 14204 |
| Catalog Number | 14204 |
| Company DUNS | 316803246 |
| Company Name | Kettenbach GmbH & Co. KG |
| 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 | 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 | E217142041 [Primary] |
| 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 | 2023-06-07 |
| Device Publish Date | 2023-05-30 |
| E217148031 - Profisil | 2024-09-03 Profisil Fluoride Varnish Intro pack |
| E217148101 - Profisil | 2024-09-03 Profisil Fluoride Varnish Mint, Superbulk, 1000 x 0,5 ml, Mint |
| E217148111 - Profisil | 2024-09-03 Profisil Fluoride Varnish Berry, Superbulk, 1000 x 0,5 ml, Berry |
| E217148121 - Profisil | 2024-09-03 Profisil Fluoride Varnish Berry, Superbulk, 1000 x 0,5 ml, Berry |
| E217179021 - Dynamic Mixers | 2024-09-03 Dynamic mixers, 45 pieces |
| E217148071 - Profisil | 2023-12-13 Profisil Fluoride Varnish Mint, Bulk Pack, 300 x 0,5 ml, Mint |
| E217148081 - Profisil | 2023-12-13 Profisil Fluoride Varnish Berry, Bulk Pack, 300 x 0,5 ml, Berry |
| E217148091 - Profisil | 2023-12-13 Profisil Fluoride Varnish Unflavored, Bulk Pack, 300 x 0,5 ml, Unflavored |