DESS Offers FDA-Compliant Workflow for Dental Labs

DESS® Blanks and Ti-Bases by DESS have achieved PNP FDA accreditation, making it possible for dental labs to become FDA-compliant without being FDA-registered. This development comes in response to the evolving regulatory requirements for CAD/CAM automation processes set by the FDA. 

Specifically, the 510(k) requirements for Ti blanks and Ti bases in dental implant abutments have been modified, and they now fall under Product Code NHA. This means that dental labs must become “validated milling centers” and adopt manufacturing procedures in line with Quality System regulations.

Simplifying Compliance for Dental Labs

The FDA’s regulatory requirements pose a challenge for dental laboratories that must register with the FDA and undergo FDA audits. DESS’s new Digital Dentistry Workflow aims to address this challenge by enabling non-FDA accredited labs to remain operational while still adhering to the FDA’s compliance standards. The DESS FDA 510(k) certification guarantees that any dental lab utilizing this workflow is compliant with FDA and health and safety guidelines.

According to DESS CEO Stefan Axelsson, “This is a groundbreaking innovation that offers a digital workflow to support dental labs to be FDA compliant.” He further explained, “Our Digital Dentistry Workflow products are a game-changer for labs that may not have the resources or capabilities to achieve FDA accreditation. With DESS Ti-Base, AURUMBase, ELLIPTIBase, C-Base, and Pre-milled blanks, we offer a complete, turnkey solution for non-FDA accredited labs.”

Products That Do Not Require FDA Certification

The DESS Digital Dentistry Workflow includes various products that can be used without the need for FDA certification, such as the DESS Ti-Base, AURUMBase, ELLIPTIBase, C-Base, and Pre-milled blanks. The workflow also includes 18 implant system compatibilities, scan files, CAD/CAM software, ceramic material, titanium material, milling machines, associated tooling, and accessories.

The DESS Digital Dentistry Workflow’s integration of various systems provides a solution that makes it possible for dental labs to maintain operations while still adhering to FDA compliance standards.

Click here for more information on the DESS Blanks and Ti-Bases by DESS.