Terrats Medical SL · Class II · Cleared Feb 14, 2025
| K-number | K243212 |
| Device name | DESS Dental Smart Solutions |
| Applicant | Terrats Medical SL |
| Product code | NHA |
| Device class | Class II |
| Decision date | Feb 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3630 |
DESS Dental Smart Solutions is a system of dental implant abutments and screws designed to support prosthetic crowns and bridges on endosseous dental implants in the upper and lower jaw. The abutments are available in multiple designs (healing, temporary, straight, Ti Base, AURUM Base, C-Base, ELLIPTIBase, CoCr Base, Pre-Milled Blank, Multi-Unit, and DESSLoc) to accommodate different clinical situations and are compatible with various OEM implant systems including BlueSkyBio, Alpha Dent, and Astra Tech implants.
The subject device abutments are manufactured from Ti-6Al-4V alloy (ASTM F136) or CoCr alloy (ASTM F1537), with anodization and SelectGrip® surface finish identical to predicate devices. DESSLoc abutments feature a zirconium nitride (ZrN) coating 2–3 μm thick via physical vapor deposition. Zirconia superstructures conform to ISO 13356. Abutment designs include engaging and non-engaging options with platform diameters ranging 2.8–6.8 mm and angulation options from 0° to 30°. Sterilization is by gamma irradiation (25 kGy) or moist heat, with 5-year shelf life validated per ASTM F1980.
ASTM F136 (titanium alloy), ASTM F1537 (CoCr alloy), ISO 13356 (zirconia), ANSI/AAMI/ISO 17665-1 and TIR 17665-2 (moist heat sterilization), ISO 11137-1 and 11137-2 (gamma sterilization), ANSI/AAMI ST72 (bacterial endotoxin testing), ASTM F1980 (accelerated aging). MR safety analysis referenced published literature per FDA guidance (October 2023) on magnetically induced displacement and torque.
The subject device is substantially equivalent to predicates K170588, K173908, K191986, K212628, K222288, and K240208 because all share identical intended use (functional and esthetic rehabilitation of edentulous jaw), employ the same abutment design types and materials (Ti-6Al-4V per ASTM F136, anodization, SelectGrip® surface), use identical zirconia composition and cement (Multi-Link K130436), and apply the same sterilization methods and validation standards. The only differences are the list of compatible OEM implant systems and addition of new size/angulation combinations, which do not raise new safety or effectiveness questions since OEM compatibility was established through reverse engineering dimensional analysis or contractual agreements with manufacturers, and all physical/chemical properties remain unchanged.
View the full FDA submission: accessdata.fda.gov