Class Class II
Biomic Color Opaque (K250534)
Description
Biomic Color Opaque by Aidite (Qinhuangdao) Technology Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250534
Clearance Date2025-05-20
Clearance TypeTraditional
Product CodeEIH
Regulation Number872.6660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250534
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. Biomic Color Opaque (K250534) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology ... | 2024 |
| K232676 | Dental Porcelain Powder | Chengdu Besmile Medical Technology ... | 2024 |
Trace the full predicate network for K250534
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.