Class Class II
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) (K223253)
Description
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) by Arum Dentistry Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223253
Clearance Date2023-02-27
Clearance TypeTraditional
Product CodeEIH
Regulation Number872.6660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223253
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. Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) (K223253) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190112 | Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025 |
Trace the full predicate network for K223253
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.