Class Class I
Integral Dental Unit (K243130)
Description
Integral Dental Unit by Guangdong Yadeng Medical Apparatus Co., Ltd.,, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK243130
Clearance Date2025-06-27
Clearance TypeTraditional
Product CodeEIA
Regulation Number872.6640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243130
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 Unit (K243130) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183347 | K3 | Osstem Implant Co., Ltd. | 2019 |
Trace the full predicate network for K243130
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.