| Primary Device ID | EBRETUWL3A209 |
| NIH Device Record Key | 471dbf6f-6f28-4c73-be74-3eea9b2dd331 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | neo.lign P tooth posterior |
| Version Model Number | TUWL3A20 |
| Catalog Number | TUWL3A20 |
| Company DUNS | 341086190 |
| Company Name | bredent 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBRETUWL3A200 [Primary] |
| HIBCC | EBRETUWL3A209 [Package] Contains: EBRETUWL3A200 Package: dummy [1 Units] Discontinued: 2023-08-30 Not in Commercial Distribution |
| ELM | Denture, plastic, teeth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-07 |
| Device Publish Date | 2023-08-30 |
| EBRETUWL3A209 | neo.lign P tooth posterior WL3 lower A20 8 parts (34,35,36,37/44,45,46,47) 1 Assortment |
| EBRETOWL4A209 | neo.lign P tooth posterior WL4 upper A20 8 parts (14,15,16,17/24,25,26,27) 1 Assortment |
| EBRETOWL3A209 | neo.lign P tooth posterior WL3 upper A20 8 parts (14,15,16,17/24,25,26,27) 1 Assortment |