Osstem Abutment System

GUDID 08800121732758

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800121732758
NIH Device Record Key7b56d365-740c-4263-8803-88ab8525ebb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsstem Abutment System
Version Model NumberGSTA7660NWH
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800121732758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


[08800121732758]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-19
Device Publish Date2023-05-11

On-Brand Devices [Osstem Abutment System]

08800040685012TSMTBS
08800040685005TSMTB0605GTH
08800040684992TSMTB0410GTH
08800040684985TSMTB0405GTH
08800121768863GSFSM
08800121745307TSMTB0605G
08800121745277TSMTB0410G
08800121745246TSMTB0405G
08800121745222TSMSH
08800121744768TS10PA455RWH
08800121744744TS10PA455MWH
08800121744720TS10PA454RWH
08800121744706TS10PA454MWH
08800121742207RCS02
08800121741392OAON02S
08800121740135MERS500
08800121740128MER500TH
08800121740111MER500
08800121733670GSTTA4530TH
08800121733663GSTTA4510TH
08800121733656GSTTA4030TH
08800121733649GSTTA4010TH
08800121733632GSTAS4771WH
08800121733618GSTAS4771NWH
08800121733595GSTAS4761WH
08800121733571GSTAS4761NWH
08800121733458GSTAS4671WH
08800121733434GSTAS4671NWH
08800121733410GSTAS4661WH
08800121733397GSTAS4661NWH
08800121732833GSTA7670WH
08800121732819GSTA7670NWH
08800121732796GSTA7660WH
08800121732758GSTA7660NWH
08800121732598GSTA7470WH
08800121732574GSTA7470NWH
08800121732536GSTA7460WH
08800121732512GSTA7460NWH
08800121732475GSTA7450WH
08800121732444GSTA7450NWH
08800121732413GSTA7440WH
08800121732383GSTA7440NWH
08800121732352GSTA7430WH
08800121732321GSTA7430NWH
08800121732291GSTA7420WH
08800121732260GSTA7420NWH
08800121732239GSTA7410WH
08800121732208GSTA7410NWH
08800121732178GSTA6770WH
08800121732154GSTA6770NWH

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