Class Class II
BruxZir™ Incisal Coloring Liquid (K230262)
Description
BruxZir™ Incisal Coloring Liquid by Prismatik Dentalcraft, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230262
Clearance Date2023-05-16
Clearance TypeTraditional
Product CodeEIH
Regulation Number872.6660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230262
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. BruxZir™ Incisal Coloring Liquid (K230262) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220960 | BruxZir Opaque Coloring Liquid | Prismatik Dentalcraft, Inc. | 2022 |
| K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Mo... | The Argen Corporation | 2019 |
Trace the full predicate network for K230262
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.