Class Class II
DESS Dental Smart Solutions (K221301)
Description
DESS Dental Smart Solutions by Terrats Medical SL, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221301
Clearance Date2023-03-09
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221301
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. DESS Dental Smart Solutions (K221301) cites 5 predicate devices and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222288 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 |
| K201860 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2021 |
| K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. | 2018 |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | 2016 |
| K130436 | MULTILINK HYBRID ABUTMENT CEMENT | Ivoclar Vivadent, AG | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250639 | DESS Dental Smart Solutions | Terrats Medical SL | 2025 |
| K242542 | Medentika CAD/CAM Abutments | Medentika GmbH | 2025 |
| K240982 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw... | Nobel Biocare AB | 2024 |
Trace the full predicate network for K221301
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.