SIS (Stella)

GUDID 08809457204526

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

Shinhung MST Co., Ltd.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID08809457204526
NIH Device Record Key6d1bec13-d4f9-4d1a-afb2-f2c617249e8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIS (Stella)
Version Model NumberSTR3511LS
Company DUNS689667152
Company NameShinhung MST Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr
Phone+821099545139
Emaildlwogml831@shinhung.co.kr

Device Identifiers

Device Issuing AgencyDevice ID
GS108809457204526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [SIS (Stella)]

08806343906953This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906946This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906939This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906922This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906915This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906908This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906892This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906885This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906489This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906472This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906465This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906458This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906441This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906434This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906427This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08806343906410This product is used to implement fixture, abutment of oral cavity in impression acquisition and
08809457205684The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205677The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205660The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205653The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205646The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205639The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205622The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205615The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205608The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205592The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205585The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205578The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205561The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205554The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205547The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205530The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205523The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205516The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205509The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205493The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205486The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205479The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205462The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205455The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205448The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205431The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205424The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205417The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205400The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205394The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205387The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205370The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205363The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
08809457205356The Stella is intended to be surgically placed in the upper or lower jawbone to provide support

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