Class Class II
Ceramic Etchant (HF-5 and HF-9) (K240153)
Description
Ceramic Etchant (HF-5 and HF-9) by Liaoning Upcera Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240153
Clearance Date2024-10-02
Clearance TypeTraditional
Product CodeKLE
Regulation Number872.3200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240153
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. Ceramic Etchant (HF-5 and HF-9) (K240153) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024 |
Trace the full predicate network for K240153
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.