ET US SS Prosthetic system

GUDID 08800000972992

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000972992
NIH Device Record Keyc84d46db-8fa9-4895-ad40-8cafa3ac1726
Commercial Distribution StatusIn Commercial Distribution
Brand NameET US SS Prosthetic system
Version Model NumberCAR544NTH
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
GS108800000972992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000972992]

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 [ET US SS Prosthetic system]

08800000974651SSS487
08800000974644SSS485P
08800000974637SSS485
08800000974620SSS484P
08800000974613SSS484
08800000974606SSEC605
08800000974590SSEC604
08800000974583SSEC487
08800000974576SSEC485
08800000974569SSEC484
08800000974552SSE607
08800000974545SSE605P
08800000974538SSE605
08800000974521SSE604P
08800000974514SSE604
08800000974507SSE487P
08800000974491SSE487
08800000974484SSE485P
08800000974477SSE485
08800000974460SSE484P
08800000974453SSE484
08800000974446SSCAP4846CTH
08800000974439SSCA607N
08800000974422SSCA607
08800000974415SSCA605TH
08800000974408SSCA605NTH
08800000974392SSCA605N
08800000974385SSCA605
08800000974378SSCA604TH
08800000974361SSCA604NTH
08800000974354SSCA604N
08800000974347SSCA604
08800000974330SSCA487TH
08800000974323SSCA487NTH
08800000974316SSCA487N
08800000974309SSCA487
08800000974293SSCA485TH
08800000974286SSCA485NTH
08800000974279SSCA485N
08800000974262SSCA485
08800000974255SSCA484TH
08800000974248SSCA484NTH
08800000974231SSCA484N
08800000974224SSCA484
08800000974217SSC605
08800000974200SSC604
08800000974194SSC487
08800000974187SSC485
08800000974170SSC484
08800000974163SSA6020TH

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