Class Class II
Dental Barrier and Sleeves (K250606)
Description
Dental Barrier and Sleeves by Yueying Medical Instruments (Langfang) Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250606
Clearance Date2025-05-29
Clearance TypeTraditional
Product CodePEM
Regulation Number878.4370
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250606
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. Dental Barrier and Sleeves (K250606) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments... | 2024 |
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019 |
Trace the full predicate network for K250606
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.