SIS (Luna)

GUDID 08809458317157

Ball Abutment Socket Assembly

Shinhung MST Co., Ltd.

Dental implant suprastructure kit

• Primary Device ID: 08809458317157
• NIH Device Record Key: c0bcd713-1ec4-4d9f-a882-bd67fb6b9f87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIS (Luna)
• Version Model Number: BAS00A
• Company DUNS: 689667152
• Company Name: Shinhung MST Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301900
• Email: syangt8823@shinhung.co.kr

Device Dimensions

• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter
• Outer Diameter: 3.6 Millimeter
• Height: 3.15 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809458317157 [Primary]
GS1	18809458317154 [Package]; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123155

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

[08809458317157]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-28
• Device Publish Date: 2015-08-31

On-Brand Devices [SIS (Luna) ]

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• 08809458310233: Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
• 08809458310226: Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
• 08809458310219: Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), t
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• 08809458310110: Ball Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
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• 08809458310059: Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809458310042: Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809458310035: Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809458310028: Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809458310011: Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809458310004: Ball Abutment Ø3.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809457209996: Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809457209989: Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809457209972: Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809457209965: Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809457209958: Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809457209941: Ball Abutment Ø3.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), ti
• 08809457209910: Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
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• 08809457209873: Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
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• 08809457209859: Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
• 08809457209842: Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
• 08809457209835: Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titaniu
• 08809457209828: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209811: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209804: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209798: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209781: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209774: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209767: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209750: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209743: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit
• 08809457209736: Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), tit