Manufacture

We will tell you in detail how we manufacture our products: dental implants and components.

 DIF Dental Implants production

MAIN REQUIREMENT FOR PRODUCTION

The main indicator of a high level of production is the quality of the manufactured product.  To provide our clients with necessary high level quality product we organized a special department consisting of professionals with experience in turning and medical production for more than 25 years, who have at their disposal advanced measuring and optical equipment that allows control all the nuances of the production process: material, product parameters, tolerances, surface treatment, sterilization and final packaging of the product.

The DIF Dental Implant system specialists constantly monitor the quality of the products at all stages of the manufacturing process and production, they draft instructions for all manufactured parts and ensure that all product lines meet the requirements of the International Organization for Standardization (ISO 9001, ISO 13485, 93/42 EEC). 

RAW MATERIAL

Titanium and its alloys are the main materials for implant manufacturing in the world dental practice. Titanium is compatible with other inert metals when in the body, without causing galvanic effect.

PRESENT DAY

At the present moment the main material for implant manufacturing is titanium, which combines optimal physicochemical and biomechanical properties, biological inertness and wide spread due to its relatively low cost.  

TITANIUM 

The main criterion of choosing a metal brand is the absence of toxic impurities. Titanium alloy with alluminium and vanadium (Ti 6Al – 4V ELI (grade 5) according to international classification, BT6 according to GOST 19807 RF* (* technical standards maintained by the Euro-Asian Council for Standardization, Metrology and Certification (EASC) increases the strength of the material by almost 2 times compared to pure titanium and reduces its specific weight.

TITANIUM PROPERTIES

The advantage of the biomechanical position is that titanium has a higher hardness than bone tissue and a modulus of elasticity similar in value to cortical bone. It aids to homogeneous stress and tension transfer in the interface area during implant loading.

DIF IMPLANTS

DIF implants are made of titanium alloy Ti 6Al-4V ELI (grade 5 according to the international classification) (BT6 according to GOST 19807 of the Russian Federation) (ratio of components: titanium 88.5%, aluminum 6%, vanadium 4%). The titanium alloy of DIF implants meets the requirements of the ASTM F136-8e1 standard "Standard specification of the deformable titanium alloy Ti 6Al-4V ELI for implant surgery".

TITANIUM BARS

TITANIUM BARS

Grade 5

READY FOR LOADING IN CNC MACHINE

TITANIUM FOR IMPLANTS

Titanium alloy grade Ti 6Al – 4V ELI

Дентальные имплантаты после станка

FINISHED PRODUCT

Implant blanks immediately after turning on a CNC machine

Sandblasting of a dental implant (video)

Implant surface modifications help to achieve improved bone contact with the implant and have a positive effect on clinical outcomes. Numerous methods are used to create nanostructured parameters of the titanium surface, among which sandblasting is the most popular.
With the help of this technique the porous layer on the implant surface is achieved due to its collision with microscopic particles. The thickness of the porous layer can be changed depending on the size of the granulated particles. The rough surface created in this way has the property of stimulating gene expression in osteoblasts, and also increases the density of the connection between the bone and the implant. 

IMPLANT SURFACE TREATMENT

The implant surface must meet certain requirements for effective osseointegration in the human jaw. Today there are about 10 types of implant processing, however, in the world practice, mainly two types are used: SLA and RBM.
SLA is an abbreviation for Sand-blasted, Large grit, Acid-etched (coarse sandblasting and acid etching). During SLA treatment, the implant surface is sandblasted, i.e. bombarded with liquid-metal mass, and then etched with acid to give it a roughness. Various materials are used as sand.
The most common bombardment materials are AL2O3 (aluminum oxide), TiO2 (titanium oxide), RBM (calcium phosphate) and BCP - biphasic calcium phosphates (calcium phosphate apatite). Particle size, pressure and duration of the bombardment affect the surface roughness characteristics. In our case, AL2O3 (aluminum oxide) is used, followed by acid etching [hydrochloric acid (HCl)/sulphuric acid (H2SO4)].
DIF implant surfaces are treated using the certified SLA method. What exactly is this surface treatment method? 

The preparation of the future dental implant is a semi-finished product - a titanium screw. Further processing of the workpiece in several stages is necessary to obtain a dental implant from it.

Очистка заготовки имплантата
IMPLANT WORKPIECE CLEANING
Stage 1

IMPLANT WORKPIECE CLEANING

Step 1: The process is carried out in a special vibroapparatus using a chemical catalyst to remove metal chips and oil.

SANDBLASTING
SANDBLASTING
STAGE 2

SANDBLASTING

SLA – 1st step: this kind of treatment is carried out in a sandblasting machine by bombarding the surface of titanium workpiece under high pressure to give its surface a roughness of 1.7 Ra.

ACID ETCHING
ACID ETCHING
STAGE 3

ACID ETCHING

The implant workpiece is immersed in acid, followed by an increase in temperature.

SANDBLASTING
SANDBLASTING
STAGE 4

SANDBLASTING

SLA – 2nd step: repeated bombardment of the surface of the implant preform after acid etching.

RE-REFINING OF THE IMPLANT PREFORM
RE-REFINING OF THE IMPLANT PREFORM
STAGE 5

RE-REFINING OF THE IMPLANT PREFORM

2nd step: refining of inclusions on the workpiece surface in the form of contaminating residual particles after final sandblasting.

IMPLANT PREFORM STERILIZATION
IMPLANT PREFORM STERILIZATION 
STAGE 6

IMPLANT PREFORM STERILIZATION 

This is the final phase of implant preform treatment, which takes place in a special sterile room, where the packaged product is exposed to gamma radiation.

DENTAL IMPLANT PACKAGING
DENTAL IMPLANT PACKAGING
STAGE 7

DENTAL IMPLANT PACKAGING

1st step: finished implant is placed together with the implant-driver and the cover screw into the PET thermoformed tray.

DENTAL IMPLANT PACKAGING
DENTAL IMPLANT PACKAGING
STAGE 6

DENTAL IMPLANT PACKAGING

2nd step: the implant is sealed with a Taivek 1073B membrane cover in a special press machine at 120-130 degrees Celsius, then packed in a box with a sticker (marking) for the doctor and patient.

QUALITY CONTROL

1. All the manufactured products must fully be in accordance with the original technical drawing. If there is a discrepancy in the quality control process, the product is discarded.
2.The cutting tool of the lathe has its endurance. The use of tools that have run out of resources significantly affects the quality of the final product, which results in a large number of defects – i.e. additional costs. DIF is not interested to incur unnecessary costs, thereby increasing the cost of products, so there is constant control over the resource of all production tools.
3. Each tenth product leaving the machine is fully inspected for compliance with the technical drawing. If a discrepancy is detected in the drawing, the entire production line is stopped to identify the cause.
4. After refining is carried out, all medical devices are re-checked electronically. 

300
products per hour go through quality control

Today the production of dental implants and their components due to technology, compliance with surface treatment requirements, high quality control at all stages has minimized errors and defects in the production process.

Maintaining the highest technological level for many years, DIF continues to successfully produce premium quality products.