OSSTEM Implant System - Abutment

GUDID 08800000970332

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000970332
NIH Device Record Key698bc49f-e0a2-4d43-9274-e91900f7eafb
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSTEM Implant System - Abutment
Version Model NumberGSRPC460
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108800000970332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000970332]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-09-21

On-Brand Devices [OSSTEM Implant System - Abutment]

08800000972329TSQTA5550TH
08800000972312TSQTA5550NTH
08800000972305TSQTA4550TH
08800000972299TSQTA4550RTH
08800000972282TSQTA4550RNTH
08800000972275TSQTA4550NTH
08800000972268TSQTA4515RTH
08800000972251TSQTA4515RNTH
08800000972244TSQTA4050MTH
08800000972237TSQTA4050MNTH
08800000972220TSQTA4015MTH
08800000972213TSQTA4015MNTH
08800000972206TSMA5050P
08800000972190TSMA5050MP
08800000972183TSMA5040P
08800000972176TSMA5040MP
08800000972169TSMA5030P
08800000972152TSMA5030MP
08800000972145TSMA5020P
08800000972138TSMA5020MP
08800000972121TSMA5010P
08800000972114TSMA5010MP
08800000972107TSCHAPR9TH
08800000972091TSCHAPR7TH
08800000972084TSCHAPR5TH
08800000972077TSCHAPM9TH
08800000972060TSCHAPM7TH
08800000972053TSCHAPM5TH
08800000972046RS01
08800000972039RCS01
08800000972022GSZAS6550WH
08800000972015GSZAS6550NWH
08800000972008GSZAS6535WH
08800000971995GSZAS6535NWH
08800000971988GSZAS5550WH
08800000971971GSZAS5550NWH
08800000971964GSZAS5535WH
08800000971957GSZAS5535NWH
08800000971940GSZAS4550WH
08800000971933GSZAS4550NWH
08800000971926GSZAS4535WH
08800000971919GSZAS4535NWH
08800000971902GSZAM4550WH
08800000971896GSZAM4550NWH
08800000971889GSZAM4535WH
08800000971872GSZAM4535NWH
08800000971865GSTTA4530TH
08800000971858GSTTA4530NTH
08800000971841GSTTA4510TH
08800000971834GSTTA4510NTH

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