Dentin Standards and Regulations CE FDA Approval
DENTIN The main goal of quality is the key to success .The procedure is safe and continuously improves processes for Dental Implants. The performance of the implant is even better than the winning formula and has been justified by technological and quality control results, especially by results of sample analyses done by SEM-EDS and XPS techniques. For the visible area, clean surface and no particles remaining behind the treatment within the surface area of 100X100 microns.
Standards and Regulations CE FDA Approval:
DENTIN implant products, processes and services comply Dental Implants FDA Approval 510(K) FDA Number K120530, with ISO 9001: 2008 – quality management system, ISO 13485:2003 quality management system for medical devices and Medical Device Directive 93/42 EEC:1993.All DENTIN products are marked with batch numbers and all raw materials are monitored from the moment of their arrival to the manufacturing plant. All the DENTIN products are subject to strict quality control at all stages of production.
DENTIN products undergo a very severe sterilization procedure – exposure to gamma rays at an intensity of 2.25 M.RAD, in accordance with the strictest requirments of European laws and directives.
DENTIN’s quality management team consists of experienced staff who conduct internal and external audits. Internal audits closely examine the various stages of product development while external audits inspect our process and suppliers. In addition, an appointed team leader is responsible for overall control of quality assurance. Quality management is process-oriented, and quality assurance acts on a future-oriented basis. We control the quality of our products for consistency and sustainability using long-term tests made at our own locations with our own equipment.
The system of “DENTIN Implants” resolves all clinical cases. Within the system, all the elements fit together. Most implants have a common geometric platform. Despite the variety of parts they are all complementary and fit mutually together
Applicable Standards and Regulations CE, FDA, ISO:
ISO 9001: 2008
Title 21 CFR part 820 (Quality System Regulation)
Medical Device Directive 93/42 EEC:1993
Dental Implants FDA Approval 510(K) FDA Number K120530
DENTIN Implants ’s authorized regulatory representative is:
DENTIN Implants Technologies Ltd authorized regulatory representative is:
Arazy Group GmbH
Am Kalkofen 8, Wöllstadt, 61206 Germany
Tel: +49 60 34 90 59 49 – 0
Fax: +49 60 34 90 59 49 – 9