Light-curing Coloring Materials (ALCM)
Device Facts
| Record ID | K253036 |
|---|---|
| Device Name | Light-curing Coloring Materials (ALCM) |
| Applicant | Aidite (Qinhuangdao) Technology Co., Ltd. |
| Product Code | EBF · Dental |
| Decision Date | Apr 6, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
Indications for Use
This product is used for the individualized staining of directly placed and laboratory-fabricated acrylic resin restorations, composite resin restorations, and resin-based ceramics
Device Story
Light-curing Coloring Materials (ALCM) is a dental restorative accessory; used for individualized esthetic characterization of acrylic resin, composite resin, and resin-based ceramic restorations. Device consists of light-curing resin liquid containing acrylic resin, photoinitiator, and optional pigments/silicon dioxide. Supplied in PE bottles; applied by dental professionals chairside or in laboratory. Polymerization occurs via light-activated free-radical polymerization using UV/visible light (385–405 nm). Curing requires specific intensity/time parameters (chairside: ≥650 mW/cm² for 3.5 min; lab oven: ≥400 mW/cm² for 5 min). Output is a hardened, color-matched surface layer providing esthetic characterization and masking of discolored structures. Benefits include improved cosmetic appearance of dental restorations.
Clinical Evidence
No clinical data. Bench testing only. Performance evaluated per ISO 4049:2019 (appearance, water sorption, solubility, flexural strength, shear bond strength, color stability, film thickness) and ISO 20795-1:2013 (residual monomer). Biocompatibility assessed per ISO 10993-1:2018 and ISO 7405:2018 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity).
Technological Characteristics
Light-curing resin liquid. Materials: acrylic resin, photoinitiator, silicon dioxide, pigments. Curing: light-activated free-radical polymerization (385–405 nm). Form factor: liquid in 1-10 ml PE bottles. Standards: ISO 4049:2019, ISO 20795-1:2013, ISO 10993-1:2018, ISO 7405:2018. Non-sterile.
Indications for Use
Indicated for individualized staining of directly placed and laboratory-fabricated acrylic resin restorations, composite resin restorations, and resin-based ceramics.
Regulatory Classification
Identification
Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
Predicate Devices
- IPS Empress® Direct Color and IPS Empress® Direct Opaque (K121230)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 6, 2026
Aidite (Qinhuangdao) Technology Co., Ltd.
% Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lu Jiazui Rd., Pudong
Shanghai, 200120
CHINA
Re: K253036
Trade/Device Name: Light-curing Coloring Materials (ALCM)
Regulation Number: 21 CFR 872.3690
Regulation Name: Tooth Shade Resin Material
Regulatory Class: Class II
Product Code: EBF
Dated: September 22, 2025
Received: September 22, 2025
Dear Boyle Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253036 - Boyle Wang
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253036 - Boyle Wang
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K253036 | ? |
| Please provide the device trade name(s). | | ? |
| Light-curing Coloring Materials (ALCM) | | |
| Please provide your Indications for Use below. | | ? |
| This product is used for the individualized staining of directly placed and laboratory-fabricated acrylic resin
restorations, composite resin restorations, and resin-based ceramics | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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510(k) Summary
# 510(k) Summary
# K253036
This summary is submitted in accordance with 21 CFR 807.92.
## 1.0 Submission Sponsor
Name: Aidite (Qinhuangdao) Technology Co., Ltd.
Address: No.9 Dushan Road, Economic and Technological Development Zone, Qinhuangdao City, China 066004
Contact: Wang Zongyu
Tel: +86 15703272056
Fax: +86 335 8587198
## Designated Submission Correspondent
Contact: Mr. Boyle Wang
Address: Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lu Jiazui Rd., Pudong Shanghai, 200120 China
Tel: +86-21-50313932
Email: info@truthful.com.cn
Date of Preparation: April.2,2026
## 2.0 Device Information
Trade name: Light-curing Coloring Materials
Common name: Light-curing Coloring Materials
Model: ALCM
Classification name: Material, Tooth Shade, Resin
Production code: EBF
Regulation number: 21 CFR 872.3690
Classification: Class II
Panel: Dental
## 3.0 Identification of Predicate Device
510(k) Number: K121230
Trade/Product Name: IPS Empress® Direct Color and IPS Empress® Direct Opaque
Manufacturer: IVOCLAR VIVADENT AG
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510(k) Summary
## 4.0 Device Description
The subject device, Light-curing Coloring Materials (Model: ALCM), is a dental restorative accessory material intended for individualized staining of directly placed and laboratory-fabricated acrylic resin restorations, composite resin restorations, and resin-based ceramics.
The device is supplied in a non-sterile condition and packaged in food-grade PE bottles. It is available in fill volumes of 1 ml, 2.5 ml, 5 ml, and 10 ml. The formulation and manufacturing process are identical across all specifications; only the filling quantity differs.
The device is offered in a variety of shades, including Transparent, Brown, Blue, Color A Series, Color B Series, White, Off White, Dark Red, Light Red, Gray, Yellow, Pink Orange, Orange, and Purple Red.
## 5.0 Indication for Use Statement
This product is used for the individualized staining of directly placed and laboratory-fabricated acrylic resin restorations, composite resin restorations, and resin-based ceramics
## 6.0 Non-clinical Test Conclusion
**Bench Testing:**
Physical and mechanical properties of the subject device were evaluated in accordance with FDA-recognized standards ISO 4049 Dentistry – Polymer-based restorative materials and ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers.
- Performance testing including Appearance, Sensitivity to light, Water Sorption, Water Solubility, Shade consistency and Color stability, Flexural strength and Film Thickness were conducted in accordance with ISO 4049.
- Residual monomer testing were conducted in accordance with ISO 20795-1:2013. The test results demonstrated the Subject device meets the property requirements of the referenced standards.
**Biocompatibility Testing:**
The nature of body contact of materials used in the design of the Light-curing Coloring Materials were classified as being "External Communicating device with tissue/bone/dentin" with contact duration of >30 days. The biocompatibility testing was performed according to FDA currently-recognized versions of biocompatibility consensus standards ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and ISO 7405:2018 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry.
The following biological safety aspects have been addressed:
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510(k) Summary
- Cytotoxicity – ISO 10993-5
- Sensitization – ISO 10993-10
- Irritation – ISO 10993-23
- Acute Systemic Toxicity- ISO 10993-11
- Pyrogen Test- ISO 10993-11
- Mouse Lymphoma TK Assay- ISO 10993-3
- Bacterial Reverse Mutation Test- ISO 10993-3
- Subchronic Systemic Toxicity- ISO 10993-11
Sterility and Shelf-Life Testing:
The device is provided non-sterile.
From the Shelf life testing, Light-curing Coloring Materials has a shelf life of 2 years.
## 7.0 Technological Characteristics and Substantial Equivalence
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
Table 1- Comparison of Technology Characteristics
| Item | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 510(k) No. | K253036 | K121230 | |
| Product Name | Light-curing Coloring Materials | IPS Empress® Direct Color and IPS Empress®) Direct Opaque | -- |
| Product Code | EBF | EBF | Same |
| Regulation No. | 21 CFR 872.3690 | 21 CFR 872.3690 | Same |
| Class | II | II | Same |
| Intended Use/Indication for Use | This product is used for the individualized staining of directly placed and laboratory-fabricated acrylic resin restorations, composite resin restorations, and resin-based ceramics | IPS Empress Direct Color: Individualized characterization of direct and lab-fabricated composite resin restorations; masking of discolored tooth structure; characterization of chairside CAD/CAM veneers. IPS Empress Direct Opaque: Masking exposed metal surfaces when repairing defective ceramic and composite veneers intraorally; Masking of discolored tooth structure. | Same (Analysis 1) |
| Prescription Use | Yes | Yes | Same |
| Technology | Light-curing resin liquid for dental restorative surface staining (applied) | Light-curing resin liquid for esthetic characterization | Same |
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510(k) Summary
| | chairside or in laboratory) | (surface staining/glazing) of direct and indirect composite resin restorations and CAD/CAM veneers | |
| --- | --- | --- | --- |
| Materials | --The transparent color of this product consists solely of acrylic resin and photoinitiator. --Other colors consist of acrylic resin, silicon dioxide (silica), pigment, and photoinitiator. | --Brown shade: Bis-GMA, D3MA, UDMA, silicone oxide, TEGDMA, camphorquinone, aminobenzoate; --Remaining shades: Bis-GMA, UDMA, TEGDMA, silicone oxide | Similar |
| Materials Shades | Transparent, Brown, Blue, Color A Series, Color B Series, White, Off White, Dark Red, Light Red, Gray, Yellow, Pink Orange, Orange, Purple Red. | White, Honey Ochre, Blue Grey, Brown | Different (Analysis 2) |
| Shelf-Life | 2 years | 2 years | Same |
| Polymerization (Curing) Method | Light-activated free-radical polymerization of acrylic-resin based coloring material. Curing requires UV/visible light 385–405 nm. Solidification occurs via photoinitiator activation, forming both chemical bonds and mechanical retention with the substrate. | IPS Empress Direct Color cures with light in the wavelength range of 400–500 nm. | Similar |
| Polymerization Equipment | Chairside curing light (≥650 mW/cm², 3.5 min, ≤4 mm distance, 385–405 nm); Laboratory curing oven (≥400 mW/cm², 5 min, 385–405 nm). | Chairside curing light, 400–500 nm wavelength; 500–900 mW/cm² for 20 s or 1000–1300 mW/cm² for 10s | Different (Analysis 3) |
| Performance Testing | ISO 4049:2019 | ISO 4049:2019 | Same |
| Appearance | The product is a homogeneous liquid without visible impurities or foreign matter. | Homogeneous light-curing resin liquid, shade-specific, free of visible impurities | Same |
| Water Sorption | 23.94 ug/mm3 | 24.69 ug/mm3 | Different (4) |
| Water Solubility | 0.57 ug/mm3 | 1.69 ug/mm3 | |
| Flexural Strength | 187.738 MPa | 185.586 MPa | |
| Shear bond strength | 22.94MPa | 17.73MPa | |
| Dyeability | Purple: 17.09
Transparent color: 0.69
Brown: 10.08 | Brown: 8.45
Grey: 4.74 | |
| Staining resistance | Purple: Red wine- △ E = 2.58; Coffee- △ E = 3.16; Coke- △ E = | Brown: Red wine- △ E = 1. 31; Coffee- △ E = 0.74; Coke- △ E = | |
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510(k) Summary
| | 2.67
Brown: Red wine- △ E = 2.61; Coffee- △ E = 3.84; Coke- △ E = 3.07
Grey: Red wine- △ E = 2.44; Coffee- △ E = 2.28; Coke- △ E = 2.52 | 1.63
Grey: Red wine- △ E = 7.23; Coffee- △ E = 5.04; Coke- △ E = 1.86 | |
| --- | --- | --- | --- |
| Particle size | 152.01nm | 191.235nm | |
| Film Thickness | Transparent: 7.0μm;
Purple Red: 7.2μm;
Brown: 7.4μm | Brown: 7.4μm
Gray: 7.6μm | |
| Residual Monomer | Meet the requirement of ISO 20795-1:2013, residual monomer (MMA)≤2.2%.
Transparent: 0.030%
Brown: 0.027%
Purplish Red: 0.028% | Not publicly Available | Different (5) |
| Sterile | Non-sterile | Non-sterile | Same |
| Biocompatibility | Comply with ISO 10993-1:2018, and ISO 7405:2018 | Comply with ISO 10993-1, ISO 7405:2018 | Same |
# Analysis*:
1) The "Indication for Use" of Light-curing Coloring Materials and IPS Empress® Direct Color are considered substantially equivalent. Both the subject and predicate devices are intended to provide individualized esthetic characterization of dental restorative materials. The subject device is intended for individualized staining/characterization of resin-based restorations and ceramics, which falls within the same overall purpose as the predicate device. Therefore, the intended use of the subject device is substantially equivalent to that of the predicate device.
2) The subject device offers a broader range of material shades compared to the predicate device; however, this difference only reflects an expansion of available color options for esthetic customization. It does not alter the fundamental formulation, mechanism of action, or intended clinical use. Both devices serve the same purpose of esthetic characterization of dental restorations. Therefore, the difference in shade availability does not raise new safety or effectiveness concerns and the subject device is substantially equivalent to the predicate device.
3) The subject device specifies curing using light sources in the 385-405 nm range with defined intensity and time conditions, while the predicate device specifies curing in the 400-500 nm range with alternative intensity-time combinations. These differences represent variations in the curing parameters and acceptable equipment, but both devices rely on the same fundamental mechanism of light-activated polymerization via photoinitiator activation. The differences do not introduce a new
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510(k) Summary
mechanism of action or clinical use, and both devices achieve comparable curing of resin-based restorative materials. Since both devices are designed for the same intended use, have similar technological principles, and meet the performance standards of ISO 4049:2019, the differences do not affect their substantial equivalence.
4) Both the subject device and the predicate device (IPS Empress® Direct Color, K121230) were evaluated according to the requirements of ISO 4049:2019 Dentistry—Polymer-based restorative materials. Comparative testing was conducted on key performance attributes including appearance, sensitivity to ambient light, water absorption, solubility, color stability, shear bond strength, dyeability, color masking, flexural strength, staining resistance, particle size and film thickness. The results demonstrated that the subject device met all applicable ISO 4049:2019 criteria and showed no significant differences compared to the predicate device. Therefore, the performance characteristics of the subject device are considered substantially equivalent to those of the predicate device.
5) Residual monomer testing for the subject device was conducted in accordance with ISO 20795-1:2013, demonstrating residual monomer (MMA) levels ≤2.2%, with measured values (0.027%–0.030%) well below the acceptance limit. Although residual monomer data for the predicate device are not publicly available, both devices are composed of similar polymer-based materials and are subject to the same recognized standards and regulatory expectations. Biocompatibility for both devices complies with ISO 10993-1 and ISO 7405, indicating comparable biological safety profiles. Therefore, these differences do not affect the conclusion of substantial equivalence.
## 8.0 Summary of Clinical Test
Clinical testing was not required for this submission.
## 9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device.
