Home GUDID 08809458310004
SI
Primary DI 08809458310004
Brand SI
Company Shinhung MST Co., Ltd.
Model SBA35R10
Device description Ball Abutment Ø3.5 RPThe 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
Published 2015-08-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name NHA Abutment, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NHA Abutment, Implant, Dental, Endosseous Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18809458310001 Package GS1 12 In Commercial Distribution 08809458310004 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 18809458310001 18809458310001 08809458310004 08809458310004 8809458310004
GMDN Terms# Term, Definition table Term Definition Dental implant suprastructure, permanent, preformed A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
Device Sizes# Type, Value, Unit table Type Value Unit Height 3.2 Millimeter Length 10.17 Millimeter Outer Diameter 3.6 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 1 Degrees Celsius 30 Degrees Celsius
Sterilization Methods# Method table Method Dry Heat Sterilization Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 689667152 Device count 1 Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08806343912961 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF220 2026-04-13 08806343912978 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF320 2026-04-13 08806343912985 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF420 2026-04-13 08806343912992 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF520 2026-04-13 08806343913005 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF620 2026-04-13 08806343913012 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF125 2026-04-13 08806343913029 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF225 2026-04-13 08806343913036 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF325 2026-04-13 08806343913043 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF425 2026-04-13 08806343913050 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF525 2026-04-13 08806343913067 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF625 2026-04-13 08806343913074 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF130 2026-04-13 08806343913081 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF230 2026-04-13 08806343913098 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF330 2026-04-13 08806343913104 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF430 2026-04-13 08806343913111 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF530 2026-04-13 08806343913128 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF630 2026-04-13 08806343913135 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF135 2026-04-13 08806343913142 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF235 2026-04-13 08806343913159 MAGDEN DENTAL IMPLANT SYSTEM S.MAGFIT IP-GF335 2026-04-13
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