SIS (Luna)

GUDID 08809457208944

Duo Abutment Ø4.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna 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 function

Shinhung MST Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08809457208944
NIH Device Record Key06ea4960-d796-4922-94df-b24c50267d54
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIS (Luna)
Version Model NumberSDAN4553
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

Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 Millimeter
Height5.5 Millimeter
Outer Diameter4.6 Millimeter
Length10.6 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
GS108809457208944 [Primary]
GS118809457208941 [Package]
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

[08809457208944]

Dry Heat Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

[08809457208944]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-08-31

On-Brand Devices [SIS (Luna) ]

08809458310240Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310233Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310226Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310219Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310202Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310196Screw Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310189Screw Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310172Screw Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310165Screw Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310158Screw Abutment Ø4.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310141Screw Abutment Ø4.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310134Screw Abutment Ø4.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310127Screw Abutment Ø4.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
08809458310110Ball Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310103Ball Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310097Ball Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310080Ball Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310073Ball Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310066Ball Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310059Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310042Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310035Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310028Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310011Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809458310004Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809457209996Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809457209989Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809457209972Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809457209965Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809457209958Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809457209941Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
08809457209910Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209903Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209897Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209880Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209873Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209866Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209859Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209842Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209835Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
08809457209828Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209811Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209804Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209798Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209781Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209774Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209767Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209750Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209743Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
08809457209736Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
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