Class Class II
Glass Ceramics (K222513)
Description
Glass Ceramics by Yilink (Tianjin) Biotechnology Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222513
Clearance Date2023-02-10
Clearance TypeTraditional
Product CodeEIH
Regulation Number872.6660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222513
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. Glass Ceramics (K222513) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192231 | Dental Glass Ceramics Blocks | Aidite (Qinhuangdao) Technology Co.... | 2020 |
| K110810 | ANASCIENT BREATH MONITOR | Invoy Technologies, LLC | 2011 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230487 | Dental Lithium Disilicate Glass-Ceramic | Fuzhou Rick Brown Biomaterials Co.,... | 2023 |
Trace the full predicate network for K222513
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.