| Primary Device ID | E217135801 |
| NIH Device Record Key | 89eb25d5-3ada-4e43-b690-5d9ae2381dd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visalys Tooth Primer |
| Version Model Number | 13580 |
| Catalog Number | 13580 |
| 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 | E217135801 [Primary] |
| KLE | Agent, Tooth Bonding, 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 |
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| E217148111 - Profisil | 2024-09-03 Profisil Fluoride Varnish Berry, Superbulk, 1000 x 0,5 ml, Berry |
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