Class Class II
DESS Dental Smart Solutions (K250639)
Description
DESS Dental Smart Solutions by Terrats Medical SL, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250639
Clearance Date2025-05-22
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250639
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 (K250639) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240982 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 |
| K221301 | DESS Dental Smart Solutions | Terrats Medical SL | 2023 |
| K190079 | ArgenZ HT+ | The Argen Corporation | 2019 |
| K171876 | Ceramill Zolid HT+ white | Amann Girrbach AG | 2017 |
| K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co., Ltd. | 2015 |
| K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED B... | Liaoning Upcera Co., Ltd. | 2014 |
| K110719 | ORIGIN ZIRCONIA | B&D Dental Technologies | 2011 |
| K071410 | ARGEN PEARL BRAND ZIRCONIA | The Argen Corporation | 2007 |
Trace the full predicate network for K250639
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.