SI

GUDID 08809457208623

Healing Abutment Ø4.5 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, temporary, preformed, single-use
Primary Device ID08809457208623
NIH Device Record Key9420d99d-1eb9-478a-b551-039321a08af5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSI
Version Model NumberSHAR4520
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr
Phone+82337301900
Emailsyangt8823@shinhung.co.kr

Device Dimensions

Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 Millimeter
Outer Diameter5 Millimeter
Length7.97 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
GS108809457208623 [Primary]
GS118809457208620 [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 Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2025-06-23
Device Publish Date2015-08-31

On-Brand Devices [SI]

18809457201867Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201850Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201843Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201836Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201829Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201805Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201799Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201782Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201775Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201768Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201751Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201744Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201737Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201720Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201713Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201706Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201690Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201683Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201676Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201669Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201652Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201263Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201256Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201249Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201232Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
18809457201225Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw
08809457200610Luna Ø4.0 x 15 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM
08809457209934Cover Screw The Luna Dental Implant System is intended to be surgically placed in the bone of th
08809457209927Cover Screw The Luna Dental Implant System is intended to be surgically placed in the bone of th
08809457208814Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208807Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208791Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208784Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208777Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208760Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208753Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208746Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208739Healing Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208722Healing Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208715Healing Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208708Healing Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208692Healing Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208685Healing Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208678Healing Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208661Healing Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208654Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208647Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208630Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208623Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
08809457208616Healing Abutment Ø4.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67)
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