DESS Dental Smart Solutions

DESS Dental Smart Solutions are custom dental implant abutments designed to support prosthetic restorations (crowns) in the upper or lower jaw. The abutments are fabricated using digital dentistry workflows that integrate intraoral and lab scanners, CAD/CAM software, zirconia or titanium materials, and milling machines. They attach to endosseous dental implants and serve as an interface between the implant and the dental restoration.

The subject device expands the predicate's digital dentistry workflow by adding new options for zirconia materials (nine specific grades), scanners (four models), CAM software (four platforms), and milling machines (sixteen models). All abutment designs, implant compatibilities, and design parameters remain unchanged. Abutments are made from titanium alloy (ASTM F136) or cobalt-chromium alloy (ASTM F1537) with anodization and SelectGrip surface treatment. Base abutments support ceramic superstructures with minimum wall thickness of 0.4 mm and specified post heights; pre-milled blanks have similar constraints with 30° maximum angulation for select implant systems.

Sterilization validation per ISO 17665-1, ISO 17665-2, and ISO 14937; biocompatibility testing per ISO 10993-5 and ISO 10993-12; zirconia conformance to ISO 6872 (Dentistry – Ceramic Materials); titanium material conformance to ASTM F136; cobalt-chromium conformance to ASTM F1537. CAM restriction zone validation and software verification testing of design parameter restrictions were performed.

The subject device is substantially equivalent because all abutment part numbers, designs, and implant compatibilities were previously cleared under K221301 and K240982. The current submission only expands the validated digital dentistry workflow by including additional predicate-cleared materials (nine zirconia types already FDA-cleared), scanners, CAM software, and milling equipment. Since the physical abutments themselves are identical to those already cleared and manufactured through the same validated milling centers or equivalent digital workflows using the same materials and surface treatments, the addition of alternative workflow components does not alter the device's fundamental safety or effectiveness profile.