| Primary Device ID | 00844868047766 |
| NIH Device Record Key | 3450d0c1-2922-4043-b643-81f7e1043e9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSX® Immediate Molar Implant |
| Version Model Number | TSXIM8D8L |
| Company DUNS | 186127825 |
| Company Name | BIOMET 3I, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844868047766 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-10 |
| Device Publish Date | 2025-03-01 |
| 00844868047803 | TSX® Immediate Molar Implant, 9mmD, 8mmL |
| 00844868047797 | TSX® Immediate Molar Implant, 9mmD, 6mmL |
| 00844868047780 | TSX® Immediate Molar Implant, 9mmD, 11.5mmL |
| 00844868047773 | TSX® Immediate Molar Implant, 9mmD, 10mmL |
| 00844868047766 | TSX® Immediate Molar Implant, 8mmD, 8mmL |
| 00844868047759 | TSX® Immediate Molar Implant, 8mmD, 6mmL |
| 00844868047742 | TSX® Immediate Molar Implant, 8mmD, 11.5mmL |
| 00844868047735 | TSX® Immediate Molar Implant, 8mmD, 10mmL |
| 00844868047728 | TSX® Immediate Molar Implant, 7mmD, 8mmL |
| 00844868047704 | TSX® Immediate Molar Implant, 7mmD, 6mmL |
| 00844868047698 | TSX® Immediate Molar Implant, 7mmD, 11.5mmL |
| 00844868047674 | TSX® Immediate Molar Implant, 7mmD, 10mmL |