Class Class I
Integral Dental Units (K242611)
Description
Integral Dental Units by Mipont Medical Equipment Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK242611
Clearance Date2025-05-27
Clearance TypeTraditional
Product CodeEIA
Regulation Number872.6640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242611
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. Integral Dental Units (K242611) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233921 | Luvis Chair (LC700C) | Dentis Co., Ltd. | 2024 |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co.... | 2024 |
Trace the full predicate network for K242611
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.