FDA

The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs and medical appliances. In the simplest terms, “FDA approval” means that the FDA has decided the benefits of theapproved item outweigh the potential risks for the item’s planned use.

Quality management system / ISO 13485

Certifies the quality management system and ISO 13485 for the production and marketing of products for dental use in the following product lines:
– Acrylic Resin Teeth and Acrylic Resin for dental use.
– Anesthetics injectable solutions for dental use.
– Paper Points for dental use.
– Alloy for dental amalgam.
– Cotton for dental use and other uses.

CE 0373 / ISO 22112

– EC 0373: Certification granted for acrylic teeth resins and acrylic resins in the European Community.
– ISO 22112: Specifies the classification, requirements and test methods for synthetic polymers and teeth that are manufactured for use in prostheses used in dentistry.

INVIMA

– Good Manufacturing Practice
– Anesthetics injectable solutions for dental use.

Quality management system / ISO 13485

Certifies the quality management system and ISO 13485 for the production and marketing of products for dental use in the following product lines:
– Acrylic Resin Teeth and Acrylic Resin for dental use.
– Anesthetics injectable solutions for dental use.
– Paper Points for dental use.
– Alloy for dental amalgam.
– Cotton for dental use and other uses.

C.C.A.A.
– Importation certificate of medical devices.