Differentiality of Mega'Gen Implant
The manufacturing process of Megagen Co. Ltd. is differentiated from the material selection step.
The internationally most accepted excellent material is selected and reprocessed by strict processing steps.
 Titanium
Imported products from C-company in round bar form
Uses the Pure Titanium raw material based on ASTM F-67 guideline
Passed 8 categories of Biological Safety Tests according to International Organization for Standardardization (ISO)
Store initial physical test and Mill sheet
 MCD Apatitic Abrasive
Imported from Himed Company in USA in powder form
More than 85% of Biologically active Hydroxyapatitie (HA) powder within a body
Certified its component and nontoxicity by Material Safety Data Sheet (MSDS).
Reselected by mesh size right after the raw material importation to acquire homogenous surface status of Implant fixture.
 GOLD
Self developed by Megagen Research & Development Team in round bar form
Based on ISO1562 standard, it is high noble Gold alloy containing more than 75% of Gold and Platinum.
Composition : Au + Pt + Pd + Ir
Passed 4 categories of Biological Safety Tests according to the Test guideline of ISO
 Plastic
Imported raw material from Dupont Company in preprocessed rod form
Certified its component and nontoxicity by Material Safety Data Sheet (MSDS).
Passed 4 categories of Biological Safety Tests according to the Test guideline of ISO
Retrival temperature more than 333C.
 Medical Device Package & Label
Imported packaging materials for medical devices from Dupont company in lid & pouch forms.
Certified from materials to manufacturing processes.
Certified materials by several foreign international standard tests.
The special material which allows the permeation of air, but protects the invasion of water like liquid substances along with the resistance against microorganisms.
Have high tear & puncture resistance, and even the Ehylene Oxide, Steam, and Gamma Radiation Sterilization is possible.
Certified its safety in product storage more than 5 years through the Accelerated and Real time Aging Test under severe test condition.
The label attached to the packaging material uses the BGVV certified gluing agent which corresponds to the international safety management guide without harm on human body.
   
 CNC Machine
The latest CNC Machine allowing one-click all processing
Precise processing within the minimum allowance limit of error
Maintain the accumulated technology and excellent human resources
Perform a lot test for the initially processed products
Select only the passed products through mid-evaluation, but the unpassed products are destoryed in principal.
Operates an implant use only machine to manufacture the highest quality products
Operates a Gold product use only special processing room
 
 Sandblasting Machine
 
 Inspection
 
Quality evaluation is the life of our MegaGen.
Strict quality evaluation
Specialized evaluator
Owns several test equipments which allow high magnification and high precision measurement
Use of Lot test in all products
 Packing & Labeling
Use of safety and nontoxicity certified packing material
Auto-sealing M/C packing by using a designated pressure, temperature, and sealing time
Maintains the optimum adhesive strength at the time of product opening
Automatic label output through the establishment of an ERP system
 Laser Marking Machine
 
High speed and High precision Marking
Marking performance with excellent position accuracy
Deliver an accurate information regard on products to a user by the position marking of a Surgical tool or by size marking of a prosthesis
 Clean Room & Washing
 
Maintains the Class 10,000 level
Periodic measurement of floating microorganisms in the clean room.
Performs the final washing within the clean room
 Sterilization
 
Application of radiological (γ-ray) sterilization technique
To acquire an accurate sterilization dose, certified the accurate sterilization dose by ISO 11137 and several other tests
Store irradiation certificates for all γ-ray sterilized products issused by a special servicing firm
Specified to store bioburden test method and result for every 3 months
 Packing
 
Use of medical device use only packing material
Packing & Labeling considering user convenience
Multiple packing for safe storage of products