Class Class II
Combi Touch (K231391)
Description
Combi Touch by Mectron S.P.A., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231391
Clearance Date2023-05-15
Clearance TypeTraditional
Product CodeELC
Regulation Number872.4850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231391
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. Combi Touch (K231391) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019 |
| K140965 | MULTIPIEZO PRO, MULTIPIEZO | Mectron S.P.A. | 2014 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251425 | turbodent touch | Mectron S.P.A. | 2025 |
Trace the full predicate network for K231391
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.