TSX Implants

GUDID 00844868045274

TSX™ IMPLANT, 6.0MMD, 10MML

BIOMET 3I, LLC

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID00844868045274
NIH Device Record Key9ce7a4fa-5773-4780-be59-ec53fe349662
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSX Implants
Version Model NumberTSX6B10
Company DUNS186127825
Company NameBIOMET 3I, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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 Dimensions

Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100844868045274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-04
Device Publish Date2022-09-26

On-Brand Devices [TSX Implants]

00844868045328TSX™ IMPLANT, 6.0MMD, 8MML
00844868045304TSX™ IMPLANT, 6.0MMD, 16MML
00844868045298TSX™ IMPLANT, 6.0MMD, 13MML
00844868045281TSX™ IMPLANT, 6.0MMD, 11.5MML
00844868045274TSX™ IMPLANT, 6.0MMD, 10MML
00844868045267TSX™ IMPLANT, 5.4MMD, 8MML
00844868045243TSX™ IMPLANT, 5.4MMD, 16MML
00844868045236TSX™ IMPLANT, 5.4MMD, 13MML
00844868045229TSX™ IMPLANT, 5.4MMD, 11.5MML
00844868045212TSX™ IMPLANT, 5.4MMD, 10MML
00844868045205TSX™ IMPLANT, 4.7MMD, 8MML
00844868045182TSX™ IMPLANT, 4.7MMD, 16MML
00844868045175TSX™ IMPLANT, 4.7MMD, 13MML
00844868045168TSX™ IMPLANT, 4.7MMD, 11.5MML
00844868045151TSX™ IMPLANT, 4.7MMD, 10MML
00844868045144TSX™ IMPLANT, 4.1MMD, 8MML
00844868045120TSX™ IMPLANT, 4.1MMD, 16MML
00844868045113TSX™ IMPLANT, 4.1MMD, 13MML
00844868045106TSX™ IMPLANT, 4.1MMD, 11.5MML
00844868045090TSX™ IMPLANT, 4.1MMD, 10MML
00844868045083TSX™ IMPLANT, 3.7MMD, 8MML
00844868045076TSX™ IMPLANT, 3.7MMD, 16MML
00844868045069TSX™ IMPLANT, 3.7MMD, 13MML
00844868045052TSX™ IMPLANT, 3.7MMD, 11.5MML
00844868045045TSX™ IMPLANT, 3.7MMD, 10MML
00844868045038TSX™ IMPLANT, 3.1MMD, 8MML
00844868045021TSX™ IMPLANT, 3.1MMD, 16MML
00844868045014TSX™ IMPLANT, 3.1MMD, 13MML
00844868045007TSX™ IMPLANT, 3.1MMD, 11.5MML
00844868044994TSX™ IMPLANT, 3.1MMD, 10MML
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