US/SS/GS System

GUDID 08809892341022

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08809892341022
NIH Device Record Keyed4eea07-56c9-4999-8098-aabee89b1ba2
Commercial Distribution StatusIn Commercial Distribution
Brand NameUS/SS/GS System
Version Model NumberERAR517CTH
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

Customer Support Contacts

Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809892341022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


[08809892341022]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-04

On-Brand Devices [US/SS/GS System]

08800000981154GSCTC400WH
08800000967806OARCS
08800000961262OAO400S
08800000961255GSCTC400NWH
08800000961248CAM427TH
08800000961163GSCTC500WH
08800000907802CAM427
08800000907796CAM427N
08800000907789CAM427NTH
08800000907772CAM427NWH
08800000907765CAM427TH
08800000907758CAM427WH
08800000907741CAM447
08800000907734CAM447N
08800000907727CAM447NTH
08800000907710CAM447NWH
08800000907703CAM447TH
08800000907697CAM447WH
08800000907680CAR514
08800000907673CAR514N
08800000907666CAR514NTH
08800000907659CAR514NWH
08800000907642CAR514TH
08800000907635CAR514WH
08800000907628CAR515
08800000907611CAR515N
08800000907604CAR515NTH
08800000907598CAR515NWH
08800000907581CAR515TH
08800000907574CAR515WH
08800000907567CAR517
08800000907550CAR517N
08800000907543CAR517NTH
08800000907536CAR517NWH
08800000907529CAR517TH
08800000907512CAR517WH
08800000907505CAR524
08800000907499CAR524N
08800000907482CAR524NTH
08800000907475CAR524NWH
08800000907468CAR524TH
08800000907451CAR524WH
08800000907444CAR525
08800000907437CAR525N
08800000907420CAR525NTH
08800000907413CAR525NWH
08800000907406CAR525TH
08800000907390CAR525WH
08800000907383CAR527
08800000907376CAR527N

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