Class Class II
EZ Bond Universal (K230009)
Description
EZ Bond Universal by Meta Biomed Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230009
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeKLE
Regulation Number872.3200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230009
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. EZ Bond Universal (K230009) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K110302 | ADHESIVE EXL-759 | 3M Espe AG | 2011 |
Trace the full predicate network for K230009
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.