TSX® Immediate Molar

GUDID 00844868048565

TSX® Immediate Molar Surgical Kit, Unpopulated

BIOMET 3I, LLC

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID00844868048565
NIH Device Record Key52c40e5b-83de-4ca4-864a-8b9275010301
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSX® Immediate Molar
Version Model NumberIMKITTSXUNP
Company DUNS186127825
Company NameBIOMET 3I, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com
Phone+1(800)342-5454
EmailDentalCS@zimvie.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844868048565 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-20
Device Publish Date2025-03-12

On-Brand Devices [TSX® Immediate Molar]

00844868048749TSX® Immediate Molar Tooling Module, Unpopulated
00844868048732TSX® Immediate Molar Bone Taps Module, Unpopulated
00844868048725TSX® Immediate Molar Surgical Module, Unpopulated
00844868048565TSX® Immediate Molar Surgical Kit, Unpopulated

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