HU/HS/HG Prosthetic System

GUDID 08800000914268

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000914268
NIH Device Record Key7d68b7df-f4a0-4215-93ea-d00c5c53ee14
Commercial Distribution StatusIn Commercial Distribution
Brand NameHU/HS/HG Prosthetic System
Version Model NumberHUCMA50404RHW
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
GS108800000914268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000914268]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-07

On-Brand Devices [HU/HS/HG Prosthetic System]

08800000914770HUHLA4003M
08800000914763HUHLA4005M
08800000914756HUHLA4103R
08800000914749HUHLA4105R
08800000914732HUHLA4107R
08800000914725HUHLA5002R
08800000914718HUHLA5003R
08800000914701HUHLA5004R
08800000914695HUHLA5005R
08800000914688HUHLA5007R
08800000914671HUHLA5103W
08800000914664HUHLA5105W
08800000914657HUHLA6002R
08800000914640HUHLA6002W
08800000914633HUHLA6003R
08800000914626HUHLA6003W
08800000914619HUHLA6003WP
08800000914602HUHLA6004R
08800000914596HUHLA6004W
08800000914589HUHLA6005R
08800000914572HUHLA6005W
08800000914565HUHLA6005WP
08800000914558HUHLA6007R
08800000914541HUHLA7002W
08800000914534HUHLA7003W
08800000914527HUHLA7004W
08800000914510HUHLA7005W
08800000914503HUHLA8003W
08800000914497HUHLA8005W
08800000914480HUCMA4027MHW
08800000914473HUCMA4027MNW
08800000914466HUCMA4047MHW
08800000914459HUCMA4047MNW
08800000914442HUCMA50104RHW
08800000914435HUCMA50104RNW
08800000914428HUCMA50105RHW
08800000914411HUCMA50105RNW
08800000914404HUCMA50107RHW
08800000914398HUCMA50107RNW
08800000914381HUCMA50204RHW
08800000914374HUCMA50204RNW
08800000914367HUCMA50205RHW
08800000914350HUCMA50205RNW
08800000914343HUCMA50207RHW
08800000914336HUCMA50207RNW
08800000914329HUCMA50304RHW
08800000914312HUCMA50304RNW
08800000914305HUCMA50305RHW
08800000914299HUCMA50305RNW
08800000914282HUCMA50307RHW

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