SS System

GUDID 08800000909875

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000909875
NIH Device Record Key4427d7f1-4a1f-4d2a-b5b7-9d6e38206ac7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSS System
Version Model NumberSSCAP606C
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
GS108800000909875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000909875]

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 [SS System]

08800000910260SSCS480
08800000910253SSCS600
08800000910246SSCS480N
08800000910239SSCS600N
08800000910222SSH482
08800000910215SSH483
08800000910208SSH484
08800000910192SSH603
08800000910185SSS484
08800000910178SSS485
08800000910161SSS487
08800000910154SSS604
08800000910147SSS605
08800000910130SSC484  
08800000910123SSC485
08800000910116SSC487 
08800000910109SSC604
08800000910093SSC605
08800000910086SSPG484
08800000910079SSPG485
08800000910062SSPG487
08800000910055SSPG604
08800000910048SSPG605
08800000910031SSE484
08800000910024SSE485
08800000910017SSE487
08800000910000SSE604
08800000909998SSE605
08800000909981SSEC484
08800000909974SSEC485
08800000909967SSEC487
08800000909950SSEC604
08800000909943SSEC605
08800000909936SSCA484
08800000909929SSCA485
08800000909912SSCA487
08800000909905SSCA604
08800000909899SSCA605
08800000909882SSCAP486C
08800000909875SSCAP606C
08800000909868SSA4815
08800000909851SSA4820
08800000909844SSA6015
08800000909837SSA6020
08800000909820COG480S
08800000909813COG480B
08800000909806COG600S
08800000909790COG600B
08800000909783SSOA480
08800000909776SSOA600

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