SIS(Luna)

GUDID 18809458319899

Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction.

Shinhung MST Co., Ltd.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID18809458319899
NIH Device Record Key4f943693-503c-4235-a7e0-df617ea7ff2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIS(Luna)
Version Model NumberSAA4525N20HF
Company DUNS689667152
Company NameShinhung MST Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr
Phone+82337301907
Emailsyangt8823@shinhung.co.kr

Device Dimensions

Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter
Height8 Millimeter
Outer Diameter4.6 Millimeter
Length12.6 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809458319892 [Primary]
GS118809458319899 [Package]
Contains: 08809458319892
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18809458319899]

Dry Heat Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

[18809458319899]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-10-10

On-Brand Devices [SIS(Luna)]

18809458319943Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319936Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319929Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319912Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319905Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319899Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319882Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319875Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319868Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319851Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319844Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809458319837Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457209689The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136)
08809457209422Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209415Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209408Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209392Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209385Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209378Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209361Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209354Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209347Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209330Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209323Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209316Duo Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209309Duo Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209293Duo Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209286Duo Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209279The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136)
08809457209262The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136)
08809457209255The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136)
08809457209248The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136
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