FDA

SICAT passes FDA inspection and receives zero 483 observations

Bonn, July 10, 2014. SICAT GmbH & Co. KG, an ISO 9001 and ISO 13485 certified company announces today that it recently underwent an extensive United States Food and Drug Administration (FDA) inspection and received zero 483 observations from the agency.

The routine FDA inspection was conducted from June 23rd through June 26th in Bonn, Germany, where SICAT is headquartered. During the audit, the FDA thoroughly inspected SICAT’s entire quality management system to ensure compliance with federal regulations.

The inspection included a review of SICAT’s production facility, processes and procedures, training records, quality assurance and control procedures, and the company’s compliance with 21CFR820 regulations in general.

SICAT has several dental software products as well as appliances for implant placements listed with the FDA. The company’s latest product introduction, SICAT Function, a software for the diagnosis and treatment of craniomandibular dysfunctions just received 510(k) clearance in February 2014.

While maintaining the highest possible customer satisfaction and acceptance, SICAT’s main focus is on the safety and effectiveness of our products. This shows specifically in the field of guided implantology where SICAT assures the accuracy of individually manufactured surgical guides by using high-precision testing devices and protocols implemented by an expert team of dental lab technicians. To date there are no reported MDRs (medical device reports) or recalls for any of the products worldwide.

The FDA 21CFR820 inspection of SICAT GmbH & Co. KG ended with the best possible result – zero FDA Form 483 observations – which translates into “No Action Indicated” and acceptance by the United States Food and Drug Administration.

  • For further information please contact:
  • SICAT GmbH & Co. KG
  • Brunnenallee 6, 53177 Bonn, Germany
  • Phone: 0228 - 854697 - 0
  • Fax: 0228 - 854697 - 99
  • info(at)sicat.com

About SICAT
SICAT is an innovative company which was established in 2004 as a joint venture between HICAT GmbH – a spin-off of the caesar research center – and Sirona Dental Systems GmbH. Active in three-dimensional imaging with a selection of products and solutions for dental implantology, functional diagnostics and therapy as well as oral and maxillofacial surgery, SICAT concentrates on the development of user-friendly and cost-efficient software and hardware.

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