Class Class II
Hi-Bond Universal (K230465)
Description
Hi-Bond Universal by Mediclus Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230465
Clearance Date2023-05-22
Clearance TypeTraditional
Product CodeKLE
Regulation Number872.3200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230465
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. Hi-Bond Universal (K230465) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024 |
Trace the full predicate network for K230465
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.