About Oratech, llc

About company

OraTech is a GMP compliant manufacturer with a Class C Pharmacy License. OraTech manufactures and tests its products in accordance to applicable standards of the American Dental Association, Food and Drug Administration, International Organization for Standardization, and the European Medical Device Directive 93/42/EEC. Our facility is verified to ISO 13485 and particular requirements of ISO 9001 by a recognized CMDCAS Registrar and marks products accordingly with the CE mark.