| 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 |
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| E217150711 - Visalys BioCeramic Block | 2026-01-19 Visalys BioCeramic Block Chroma |
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| E217150741 - Visalys BioCeramic Block | 2026-01-19 Visalys BioCeramic Block Chroma |
| E217150761 - Visalys BioCeramic Block | 2026-01-19 Visalys BioCeramic Block Chroma |