We are committed to maintaining the supreme integrity of our products while continuing to meet and surpass industry standards. We provide our customers with the best products which are equipped with the latest technologies.
Strict inspection procedures are applied to ensure all dental implant products are in compliance with an array of regulatory standards. dibay™ has made a large investment towards a high-tech environment for designing and manufacturing dental products.
dibay™ sustains a meticulous quality control system that complies with major quality control standards ISO 9001:2008 and ISO 13485:2003.
In addition, all facilities, as well as design and production processes are routinely audited by local and international inspectors.
The entire manufacturing process is monitored and recorded for complete process traceability.
The cleanroom is used for the packaging process of all implants, followed by Gamma ray radiation for the final sterilization. dibay™ meets or exceeds the medical requirements and continuously maintains and monitors the top quality of its products.
CERTIFICATES AND STANDARDS
The medical use of our products demands that ultimate care is taken in assuring quality control throughout all our operations. Over the years that we at dibay™ have been involved in the eld of dental implants and related products, we have dedicated ourselves to a level of quality and service, striving to meet and exceed the highest standards set by the numerous regulatory agencies. dibay™ quality assurance and regulatory systems comply with ISO 9001:2008, ISO 13485:2003 and CE Certifications representing compliances with the International Standards Organization and European Medical Device Directives..
SPECIAL PROCEDURES & ANALYSES FOR QUALITY ASSURANCE:
- Identity of any surface treatments that blast the implant
- Composition of the particles
- Identity of any treatments to remove particles from implant surfaces
- Identity of agents used in particle removal
- Chemical analysis of the surface to verify that any chemicals used to remove particles have been washed from the surface
- Photomicrographs of blasted surfaces to show whether or not there are particles remaining behind on the surface
- Prior to sterilization by radiation, all implants go through a three-step process for cleaning after the manufacturing
- Examination of implant surface at both low and high magni cations by means of SEM / EDS* analysis, to ensure there are no visible abnormal impurities.
- Surface examination by means of SEM / EDS analysis: Implant surface at low magnification. No visible abnormal impurities. Implant surface at high magnification. No visible abnormal impurities.
process: (1) washing after machining, (2) aluminal blasting and (3) acid treatment
* Source: Surface Analysis of Dental Implants by SEM / EDS. The analysis was executed using the facilities of the Material Engineering Faculty of the Israel Technion Institute: FEI Quanta scanning electron microscope (SEM) and Inca X-ray analyzer attached to the electron microscope. The analysis included inspection of the surface in back scattering electrons (which due to good elemental contrast, enables detection of the impurities on the surface of the implants) and EDS analysis of the typical impurity particles.
We use an advanced and thorough implant cleaning process for all dental implants to ensure flawless surface structure and chemical composition, as well as its purity grade. All implant products follow a multi-stage cleaning process before being declared medically clean and ready for the packaging process.