Quality & International Standards

At Bioline, quality management is an integral part of the way we do business. Quality is one of our company’s core values. We believe that in order to provide quality products and service to our customers, we must think-act-implement quality at all times. Our team is comprised of highly professional and qualified personnel who all contribute, each with their own expertise, to cooperatively create the high standards we uphold. Integrity and transparency are an integral part of our organizational culture, enabling us to offer products from the highest of standards in the dental market. Bioline dental Implant in-house manufacturing facilities allow it to efficiently produce commercial quantities of implants and accurate prosthetic parts to meet US, EU, Rus, India Mexico and many other countries requirements. We have a state of the art production facility that is dedicated to providing high quality products. Each and every one of our products designed and manufactured to meet the highest level of standards worldwide and we are regulatory approved by a number of leading notify bodies.

International Regulations-Certifications

As an advanced medical certified manufacturing facility, BioLine is fully compliance with all European, directive for Medical Devise EN 93/42/EEC and ISO 13485:2016. Our factory is inspected on a regular basis by European notified Body to ensure we are comply the requirements of the standards. BioLine is authorized to operate within USA and the EEA and all regulating bodies have given their approval to BioLine. we have invested a significant amount of resources to ensure that we maintain high quality in our manufacturing processes. BioLine had gain and work according to the following standards: CE marking - Certificate Number MED 31574 EN ISO 13485:2016 - Certificate Number IL53646H FDA listing of all prosthetic part and surgical tools RUS - Russian regulation and marketing certificate Free Sale & Declarations of conformity for medical device products are available

Lifetime Warranty Policy

BioLine has complete confidence in the quality and long-term success of the products we manufacture and market, there for we offer a lifetime guarantee to all of our products. provided they are used properly and in accordance with our instruction for use and maintenance.