SI

GUDID 08809457200528

The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) 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.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809457200528
• NIH Device Record Key: 678f979d-b26a-42c5-8037-5e8775b60aba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SI
• Version Model Number: SIN3510S
• Company DUNS: 689667152
• Company Name: Shinhung MST Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• 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: +82337301907
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301907
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301907
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301907
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301907
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301907
• Email: syangt8823@shinhung.co.kr
• Phone: +82337301907
• Email: syangt8823@shinhung.co.kr

Device Dimensions

• Outer Diameter: 3.7 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 10 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809457200528 [Primary]
GS1	18809457200525 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123155

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-06-24
• Device Publish Date: 2015-08-31

On-Brand Devices [SI]

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• 18809457201706: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
• 18809457201690: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
• 18809457201683: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
• 18809457201676: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
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• 18809457201652: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
• 18809457201263: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
• 18809457201256: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
• 18809457201249: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
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• 08809457200610: Luna Ø4.0 x 15 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM
• 08809457209934: Cover Screw The Luna Dental Implant System is intended to be surgically placed in the bone of th
• 08809457209927: Cover Screw The Luna Dental Implant System is intended to be surgically placed in the bone of th
• 08809457208814: Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
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• 08809457208791: Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208784: Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208777: Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208760: Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208753: Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208746: Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208739: Healing Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208722: Healing Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
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• 08809457208654: Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208647: Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
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• 08809457208623: Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
• 08809457208616: Healing Abutment Ø4.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)