SIS(Luna)

GUDID 08809457209378

Duo Abutment Ø5.0 RP 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 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 ID	08809457209378
NIH Device Record Key	3d557dcb-7d60-4584-bbce-1fcdd554b01b
Commercial Distribution Status	In Commercial Distribution
Brand Name	SIS(Luna)
Version Model Number	SDAR5043H
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	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	+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
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
Phone	+82337301907
Email	syangt8823@shinhung.co.kr

Device Dimensions

Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 Millimeter
Height	4 Millimeter
Outer Diameter	5.1 Millimeter
Length	9.5 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809457209378 [Primary]
GS1	18809457209375 [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

[08809457209378]

Dry Heat Sterilization

[08809457209378]