Class Class II
Digital Intraoral X-Ray Sensor (K230811)
Description
Digital Intraoral X-Ray Sensor by Iray Imaging Technology (Haining) Limited, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230811
Clearance Date2023-04-21
Clearance TypeSpecial
Product CodeMUH
Regulation Number872.1800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230811
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. Digital Intraoral X-Ray Sensor (K230811) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang , Ltd. | 2021 |
Trace the full predicate network for K230811
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.