US System

GUDID 08800000910468

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000910468
NIH Device Record Key49ea0fd9-94c0-4275-9ddd-8af072b1cfee
Commercial Distribution StatusIn Commercial Distribution
Brand NameUS System
Version Model NumberASW200
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
GS108800000910468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000910468]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-05

On-Brand Devices [US System]

08800000960623HCR100
08800000960616AICM100
08800000957869MHCW100
08800000957852MHCR100
08800000957838TIHW605
08800000957821TIHW603
08800000957814AIHW705
08800000957807AIHW704
08800000957791AIHW703
08800000957784AIHW702
08800000957777AIHW605
08800000957760AIHW604
08800000957753AIHW603
08800000957746AIHW602
08800000957739AIHR607
08800000957722AIHR605
08800000957715AIHR604
08800000957708AIHR603
08800000957692AIHR602
08800000957685AIHR507
08800000957678AIHR505
08800000957661AIHR504
08800000957654AIHR503
08800000957647AIHR502
08800000957630AIHM405
08800000957623AIHM403
08800000910604OAO200
08800000910598OAA200
08800000910581OAA300
08800000910574OAA400
08800000910567OAA500
08800000910550OAA600
08800000910543OAA200S
08800000910536OAA300S
08800000910529OAA400S
08800000910512OAA500S
08800000910505OAA600S
08800000910482ASM200
08800000910475ASR200
08800000910468ASW200
08800000910451ASM300
08800000910444ASR300
08800000910437ASW300
08800000910420TASW200
08800000910413TASW300
08800000910406RASW200
08800000910390RASW300
08800000910383GS100
08800000910376GS200
08800000910369MGS100

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