Class Class I
X-Smart Pro; X-Smart Pro+ (K233865)
Description
X-Smart Pro; X-Smart Pro+ by Dentsply Sirona, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK233865
Clearance Date2024-07-24
Clearance TypeTraditional
Product CodeEKX
Regulation Number872.4200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233865
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. X-Smart Pro; X-Smart Pro+ (K233865) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 |
| K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015 |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015 |
| K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Aseptico, Inc. | 2011 |
Trace the full predicate network for K233865
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.