TS BA Fixture System

GUDID 08800209326978

Osstem Implant Co., Ltd.

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 ID08800209326978
NIH Device Record Keya9e30dc0-6bf4-46bc-aca8-5231f152e635
Commercial Distribution StatusIn Commercial Distribution
Brand NameTS BA Fixture System
Version Model NumberTS3S5007B
Company DUNS689051793
Company NameOsstem Implant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800209326978 [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 Date2022-09-06
Device Publish Date2022-08-29

On-Brand Devices [TS BA Fixture System]

08800209327050TS3S5013B
08800209327036TS3S5011B
08800209327012TS3S5010B
08800209326992TS3S5008B
08800209326978TS3S5007B
08800209326695TS3S4513B
08800209326657TS3S4511B
08800209326619TS3S4510B
08800209326572TS3S4508B
08800209326534TS3S4507B
08800209326336TS3S4013B
08800209326299TS3S4011B
08800209326251TS3S4010B
08800209326213TS3S4008B
08800209326176TS3S4007B
08800209325971TS3M3513B
08800209325933TS3M3511B
08800209325896TS3M3510B
08800209325858TS3M3508B
08800209313558BTS3S5013B
08800209313534BTS3S5011B
08800209313510BTS3S5010B
08800209313497BTS3S5008B
08800209313473BTS3S5007B
08800209313190BTS3S4513B
08800209313152BTS3S4511B
08800209313114BTS3S4510B
08800209313077BTS3S4508B
08800209313039BTS3S4507B
08800209312834BTS3S4013B
08800209312797BTS3S4011B
08800209312759BTS3S4010B
08800209312711BTS3S4008B
08800209312674BTS3S4007B
08800209312476BTS3M3513B
08800209312438BTS3M3511B
08800209312391BTS3M3510B
08800209312353BTS3M3508B
08800209386880TS3S5013B
08800209386842TS3S5011B
08800209386804TS3S5010B
08800209386767TS3S5008B
08800209386729TS3S5007B
08800209386446TS3S4513B
08800209386408TS3S4511B
08800209386361TS3S4510B
08800209386323TS3S4508B
08800209386286TS3S4507B
08800209386040TS3S4013B
08800209386002TS3S4011B

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