Light-curing Coloring Materials (ALCM)— 510(k) K253036

Name: FDA 510(k) clearance K253036
Creator: U.S. Food and Drug Administration
Published: 2026-04-06

Substantially Equivalent

Aidite (Qinhuangdao) Technology Co., Ltd.

FDA 510(k) clearance K253036 for Light-curing Coloring Materials (ALCM), Substantially Equivalent on 2026-04-06. Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2025-09-22
Decision date: 2026-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qinhuangdao, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Aidite (Qinhuangdao) Technology Co., Ltd.

view all

K251415 — Additively Manufactured Aligner Resin2025-08-27
K250534 — Biomic Color Opaque2025-05-20
K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin2025-04-30
K250811 — Dental Zirconia Ceramic2025-04-11
K250025 — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )2025-03-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.