Class Class II
MBA Biotech Implant System (K243002)
Description
MBA Biotech Implant System by MBA Biotech Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243002
Clearance Date2025-06-06
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243002
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. MBA Biotech Implant System (K243002) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 |
Trace the full predicate network for K243002
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.