Light-curing Coloring Materials (ALCM)
FDA 510(k) K253036 · Aidite (Qinhuangdao) Technology Co., Ltd.
510(k) numberK253036
Submission
- Device name
- Light-curing Coloring Materials (ALCM)
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd.
Qinhuangdao, CN - Received
- September 22, 2025
- Decision date
- April 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/31/2026SE |
| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | Ultradent Products, Inc. | 07/01/2026SE |
| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | Ivoclar Vivadent, Inc. | 07/01/2026SE |
| K261246 | SRGC-06EBF · Traditional | GC America, Inc. | 06/18/2026SE |
| K261093 | DiafilEBF · Traditional | DiaDent Group International | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | DiaDent Group International | 05/19/2026SE |
| K260805 | Dual CoreEBF · Traditional | Vericom Co., Ltd. | 05/11/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | Voco GmbH | 04/27/2026SE |
| K261356 | Dura-CrownEBF · Special | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/27/2026SE |
More from Hangzhou SHINING3D Dental Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251415 | Additively Manufactured Aligner ResinNXC · Traditional | 08/27/2025SE |
| K250534 | Biomic Color OpaqueEIH · Traditional | 05/20/2025SE |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge ResinEBF · Traditional | 04/30/2025SE |
| K250811 | Dental Zirconia CeramicEIH · Special | 04/11/2025SE |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )EIH · Traditional | 03/14/2025SE |
| K242884 | Additively Manufactured Denture ResinEBI · Traditional | 11/22/2024SE |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST)EIH · Special | 07/12/2024SE |
| K230115 | Denture Base ResinEBI · Traditional | 03/17/2023SE |
| K223742 | Dental Ceramic BlocksEBF · Traditional | 03/08/2023SE |
| K223477 | PMMA Blocks for Dental UseEBG · Traditional | 02/16/2023SE |
Questions and answers
When was Light-curing Coloring Materials (ALCM) cleared by the FDA?
Light-curing Coloring Materials (ALCM) (K253036) received a 510(k) decision of Substantially Equivalent on April 6, 2026, 196 days after the submission was received.
What is the product code of K253036?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.