| Primary Device ID | 00844868048732 |
| NIH Device Record Key | 20bb5242-2d5e-414c-8a4b-8a8f4a94aef7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSX® Immediate Molar |
| Version Model Number | IMTSXTAPSUNP |
| Company DUNS | 186127825 |
| Company Name | BIOMET 3I, LLC |
| 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 | 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 | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844868048732 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
[00844868048732]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-20 |
| Device Publish Date | 2025-03-12 |
| 00844868048749 | TSX® Immediate Molar Tooling Module, Unpopulated |
| 00844868048732 | TSX® Immediate Molar Bone Taps Module, Unpopulated |
| 00844868048725 | TSX® Immediate Molar Surgical Module, Unpopulated |
| 00844868048565 | TSX® Immediate Molar Surgical Kit, Unpopulated |