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International Organization for Standardization (ISO) certified.
At Concert Dental Labs we believe providing quality dentistry and great value does not have to mean compromising patient or your practices safety. That’s why Concert Dental Labs has made significant investments in its programs that ensure and demonstrate its facility meets or exceeds FDA requirements for dental laboratories and that its restorations perform up to the expectations set by the material and technology manufacturers it represents. Concert Dental Labs is pleased to have earned the following credentials:
Concert Dental Labs was pleased to be the first, and remains the only, ISO 9001:2008 third-party certified dental lab in the United States. This level of Quality Management Systems is among the most difficult, globally recognized, certifications to obtain and maintain and is typically reserved for the world’s largest healthcare and other manufacturing companies.
While the FDA does not offer a “certification program” it does require that all dental laboratories comply with their Code of Federal Regulations (CFR) 21 Part 820. ISO 9001:2008 requirements exceed that of the FDA’s requirements for dental laboratories and gives Concert customers an added confidence in the quality, authenticity and performance expectations of the restorations they provide their dentists. Requires annual inspections and biannual third-party audits.
The Certified Dental Laboratory certification is a program developed by the National Board for Certification in Dental Technology (NBC) to create a means for dental professionals and members of the public to identify dental laboratories which meet specific standards. Only roughly 1%, or 100 of the labs in the USA have earned this certification. By earning and maintaining our CDL designation, we are demonstrating our efforts to continually monitor and improve the quality of our restorations and the reliability and efficiency of our organization. Requires annual renewal.
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Concert Dental Labs is the nation's leading, direct-to-dentist technology lab creating the highest-quality restoration products using only FDA-approved materials.