Truabutment, Inc. · Class II · Cleared Jul 3, 2025
| K-number | K243255 |
| Device name | URIS Long Implant & Abutments |
| Applicant | Truabutment, Inc. |
| Product code | DZE |
| Device class | Class II |
| Decision date | Jul 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3640 |
The URIS Long Implant & Abutments is a dental implant system made of titanium (Grade 4) with SLA surface treatment, intended for use in partially or fully edentulous jaws to support single or multiple-unit restorations (cemented, screw-retained, or overdenture). The system includes implants in two types (straight and tapered), two platform sizes (narrow 3.5mm and regular 4.0–4.5mm), lengths of 16–18mm, and multiple abutment components for prosthetic support. It is designed for delayed loading.
The subject device has an internal hex connection and submerged fixture design, made of CP Titanium Grade 4 with sandblasted, large-grit, acid-etched (SLA) surface treatment, and is gamma-sterilized with a 5-year shelf life. Body diameters are 3.5, 4.0, and 4.5mm at lengths of 16 and 18mm. The abutments are made of Ti-6Al-4V ELI and include straight, angled, temporary, and base components in non-sterile form. These characteristics match the primary predicate (K172100) and are within the range of reference devices.
ISO 10993-1 (biocompatibility), ISO 11137-1/2/3 and ISO 11737-1/2 (sterilization), ISO 17665-1/2 (end-user sterilization), ISO 11607-1/2 and ASTM F1980-07/F88/F1140/F1929/F2096 (shelf-life), ISO 14801:2016 (fatigue testing), USP <85> and USP <161> (bacterial endotoxin), and SEM/EDS analysis.
The subject device is substantially equivalent because it has the same intended use as the primary predicate (K172100) and reference devices — rehabilitation of edentulous jaws using endosseous implants — and shares identical design principles (internal hex, submerged, threaded implants with SLA surface). Minor dimensional differences in length and abutment diameter do not affect substantial equivalence because the subject device's dimensions fall within the scope of previously cleared devices (K232418 covers 3.5–5.0mm diameters at 16–18mm lengths). All materials, sterilization methods, and abutment functions are substantially equivalent; non-clinical testing (biocompatibility, fatigue, sterilization, shelf-life) met applicable standards, supporting the claim of no new risks or failure modes.
View the full FDA submission: accessdata.fda.gov