Viewpoint: An Interview with Paul Cascone and Steaffani Dall of Argen

Paul Cascone: The FDA requires that the company perform reverse engineering on the same OEM size and platform being addressed in the application. This means that the geometry of the abutment (and screw) must be the same as the OEM within tolerances specified by the FDA. The company must then produce prototypes to demonstrate that the parts are in fact within these tolerances and that the company has the ability to fabricate the parts. The prototypes must pass fatigue tests to demonstrate that the company’s manufacturing process does not introduce spurious results. Once approval is granted, the company can sell the custom abutment.

IDT: Is that all that’s needed?

Steaffani Dall: Actually, 510(k) clearance is only part of the process. As a manufacturer of custom abutments, we must also adhere to a very strict quality management system. Argen has earned a certification in the highest standards of an ISO 13485 and the Medical Device Single Audit Program (MDSAP). MDSAP is a global approach to auditing and monitoring the safe manufacturing of medical devices. It is not a one-time pass or fail; Argen is routinely monitored to ensure we meet these standards. This provides our customers with the peace of mind in knowing we provide a consistent-quality product.

IDT: What makes ArgenIS custom abutments stand out?

Cascone: First of all, Argen controls the engineering and manufacturing processes. We have engineered an end-to-end manufacturing process to give us complete oversight of the production of our blanks, custom abutments, and final screws. Argen also has complete control over the quality which allows us to deliver a reliable and precise, OEM equivalent abutment. Next, the materials we use make a difference. The alloy Ti 6Al 4V Grade 5 is the minimally acceptable alloy for the FDA, CE, and other regulatory bodies. However, Argen uses a higher-purity version that offers improved damage tolerance and acts as insurance against breakage in the patient’s mouth. It’s one factor that allows us to provide a comprehensive warranty better than some OEMs.

Dall: Argen’s two-step fabrication process is also unique. It starts with a blank made with the proper platform and size geometry. The geometry is inspected with state-of-the-art video inspection equipment. The machine automatically inspects the critical dimensions (tolerances) and contours to ensure a proper fit with the implant. Then the abutment is milled from the blank. Inspection is done by the laser in the mill to ensure replication of the STL file and then again by technicians to ensure the machine did not miss anything. Other processes don’t allow for the same inspection protocol. Argen does all of this using customized industrial-grade mills and professional manufacturing software. This, in combination with our robotic automation, assures consistent, accurate parts.

Cascone: The kinds of mills and software sold to dental laboratories cannot produce OEM-quality abutments. The software needs to be more restrictive and the limitations of these mills do not provide the same accuracy. Similarly, most laboratories don’t have the staff to maintain this kind of equipment. Argen employs engineers who develop new routines, perform maintenance, and monitor the equipment, as well as dental technicians who have the knowledge and understanding of what laboratories are expecting in a custom abutment.

IDT: What does this mean for the laboratories who outsource their abutment milling to Argen?

Cascone: It means they have access to our wide range of options and a comprehensive warranty. We manufacture abutments for 15 different implant systems and 56 connections, and now offer an Angulated Screw Access abutment option. Most importantly, all of our abutments have a comprehensive warranty that covers both the abutment and the implant.

Dall: Argen is known for our excellent customer service, but we go even further for digital products. You have a digital representative to help you with files and uploads as well as a design team ready to help you design difficult cases. You also have easy access to review cases, make requests, or make changes as needed. Our split file guidance allows you to design the crown and abutment in one consistent workflow. Whether you send us a file or a model, Argen helps you get it done.