OSSTEM Implant System

GUDID 08800121773980

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID08800121773980
NIH Device Record Keyc36537be-6100-4a38-86b8-8e82f20f90e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSTEM Implant System
Version Model NumberTSHA609R
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
GS108800121773980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-13
Device Publish Date2021-10-05

On-Brand Devices [OSSTEM Implant System]

08800000965345TSHA805R
08800000965338TSHA709R
08800000965321TSHA707R
08800000965314TSHA705R
08800000965307TSHA704R
08800000965291TSHA703R
08800000965284TSHA609R
08800000965277TSHA607R
08800000965260TSHA605R
08800000965253TSHA604R
08800000965246TSHA603R
08800000965239TSHA509R
08800000965222TSHA507R
08800000965215TSHA505R
08800000965208TSHA504R
08800000965192TSHA503R
08800000965185TSHA459R
08800000965178TSHA459M
08800000965161TSHA457R
08800000965154TSHA457M
08800000965147TSHA455R
08800000965130TSHA455M
08800000965123TSHA454R
08800000965116TSHA454M
08800000965109TSHA453R
08800000965093TSHA453M
08800000965086TSHA409R
08800000965079TSHA409M
08800000965062TSHA407R
08800000965055TSHA407M
08800000965048TSHA405R
08800000965031TSHA405M
08800000965024TSHA404R
08800000965017TSHA404M
08800000965000TSHA403R
08800000964997TSHA403M
08800000964829GSCS30M
08800000964812GSCS30L
08800000964805GSCS30
08800000964089GSCS40S-G
08800000964072GSCS40M-G
08800000964065GSCS40L-G
08800000964058GSCS35
08800000964041GSCS35M
08800000964034GSCS35L
08800121773980TSHA609R
08800121773973TSHA805R
08800121773966TSHA709R
08800121773959TSHA707R
08800121773942TSHA705R

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