On February 2nd, 2018, Creodent Prosthetics announced that its facility located in Manhattan, New York successfully passed an inspection by the US Food and Drug Administration (FDA). The inspection carried out by a Senior FDA Inspector lasted 1 day. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued. We are proud that our Quality Management Systems and 510(k) products passed all requirements. It is an extremely satisfying result for our team and for our customers. A public report of the inspection will appear [...]
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Through the BellaTek® Encode® Empowered Laboratory program, CreoDent now have greater control, resulting in a timelier and more cost-efficient workflow with continued access to optimal prosthetics. Through the development of the BellaTek Encode Empowered program, the BellaTek Encode Impression System becomes even more powerful in the hands of laboratories around the world! Due to advancements in digital dentistry, BellaTek laboratories are now able to control the design of their CAD/CAM BellaTek Encode Abutments, experience faster turnaround times as well as enjoy a more simplified workflow to better support and serve their clinicians. Through the development of this program, laboratories [...]