Class Class II
LED Curing Lights (DB686 HALO) (K243921)
Description
LED Curing Lights (DB686 HALO) by Foshan Coxo Medical Instrument Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243921
Clearance Date2025-04-11
Clearance TypeTraditional
Product CodeEBZ
Regulation Number872.6070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243921
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. LED Curing Lights (DB686 HALO) (K243921) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co.,... | 2022 |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology... | 2022 |
| K221194 | LEDEX | Dentmate Technology Co. , Ltd. | 2022 |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 |
Trace the full predicate network for K243921
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.