ET Prosthetic System

GUDID 08800000924977

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000924977
NIH Device Record Keydc357ec4-7632-4294-bd67-c6c02acf9306
Commercial Distribution StatusIn Commercial Distribution
Brand NameET Prosthetic System
Version Model NumberHGRGA4057MP
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
GS108800000924977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000924977]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-16

On-Brand Devices [ET Prosthetic System]

08800000925110HGRGA4014MP
08800000925103HGRGA4024MP
08800000925097HGRGA4034MP
08800000925080HGRGA4044MP
08800000925073HGRGA4054MP
08800000925066HGRGA4015MP
08800000925059HGRGA4025MP
08800000925042HGRGA4035MP
08800000925035HGRGA4045MP
08800000925028HGRGA4055MP
08800000925011HGRGA4017MP
08800000925004HGRGA4027MP
08800000924991HGRGA4037MP
08800000924984HGRGA4047MP
08800000924977HGRGA4057MP
08800000924960HGRGA4514MP
08800000924953HGRGA4524MP
08800000924946HGRGA4534MP
08800000924939HGRGA4544MP
08800000924922HGRGA4554MP
08800000924915HGRGA4515MP
08800000924908HGRGA4525MP
08800000924892HGRGA4535MP
08800000924885HGRGA4545MP
08800000924878HGRGA4555MP
08800000924861HGRGA4517MP
08800000924854HGRGA4527MP
08800000924847HGRGA4537MP
08800000924830HGRGA4547MP
08800000924823HGRGA4557MP
08800000924816HGRGA4014SP
08800000924809HGRGA4024SP
08800000924793HGRGA4034SP
08800000924786HGRGA4044SP
08800000924779HGRGA4054SP
08800000924762HGRGA4015SP
08800000924755HGRGA4025SP
08800000924748HGRGA4035SP
08800000924731HGRGA4045SP
08800000924724HGRGA4055SP
08800000924717HGRGA4017SP
08800000924700HGRGA4027SP
08800000924694HGRGA4037SP
08800000924687HGRGA4047SP
08800000924670HGRGA4057SP
08800000924663HGRGA4514SP
08800000924656HGRGA4524SP
08800000924649HGRGA4534SP
08800000924632HGRGA4544SP
08800000924625HGRGA4554SP

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