Light-curing Coloring Materials (ALCM)— 510(k) K253036
Substantially EquivalentAidite (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.
Summary
Aidite (Qinhuangdao) Technology's Light-curing Coloring Materials (ALCM) are filed under product code EBF (Material, Tooth Shade, Resin). The record doesn't describe the materials beyond their name and that code name.
Class II, 21 CFR 872.3690. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
Aidite (Qinhuangdao) Technology filed from Qinhuangdao, China. The record shows 196 calendar days from receipt to decision (September 22, 2025 to April 6, 2026).
Clearance details
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd.
- Product code
- Product code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Qinhuangdao, CN
Recent devices under product code EBF
view allMore clearances from Aidite (Qinhuangdao) Technology Co., Ltd.
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