Primary Device ID | 00844868048565 |
NIH Device Record Key | 52c40e5b-83de-4ca4-864a-8b9275010301 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TSX® Immediate Molar |
Version Model Number | IMKITTSXUNP |
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 | 00844868048565 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
Moist Heat or Steam Sterilization
[00844868048565]
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 |