| Primary Device ID | E217142061 |
| NIH Device Record Key | 1eb77e96-f2a8-43ed-9c81-eb4c66b33ff2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal Adhesive |
| Version Model Number | 14206 |
| Catalog Number | 14206 |
| 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 | E217142061 [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 |
| E217150221 - Application Tips | 2025-04-11 Application Tips for Visalys Bulk Flow, 50 tips, Ø 0.9 mm |
| E217150231 - Application Tips | 2025-04-11 Application Tips for Visalys Bulk Flow, 50 tips, Ø 1.2 mm |
| E217150641 - Visalys Bulk Flow | 2025-04-11 Visalys Bulk Flow, 1 x 2 g Syringe |
| E217150661 - Visalys Bulk Flow | 2025-04-11 Visalys Bulk Flow, 15 x 0.25 g Caps |
| E217150671 - Visalys Bulk Flow | 2025-04-11 Visalys Bulk Flow Intro pack, 2 x 0.25 g Caps |
| E217148201 - Profisil | 2025-04-10 Profisil Fluoride Varnish Plus Intro pack |
| E217148211 - Profisil | 2025-04-10 Profisil Fluoride Varnish Plus Combi pack, 30 x 0,5 ml, (10 xMint, 10 xBerry, 10 xUnflavored) |
| E217148221 - Profisil | 2025-04-10 Profisil Fluoride Varnish Plus Mint Normal pack, 50 x 0,5 ml, Mint |