(67 days)
Not Found
No
The device description and performance studies focus on the physical, mechanical, and biocompatibility properties of dental porcelain materials, with no mention of AI or ML.
No.
The device is used to make cosmetic and functional components (facings and veneers) of denture crowns, not to treat a disease or condition.
No
Explanation: The device is described as a material (Porcelain Powder) used to make dental facings and veneers. Its functions relate to shaping, coloring, and glazing dental crowns, not to diagnosing a medical condition.
No
The device description explicitly lists physical components like "Porcelain Powder, Stain/Glaze, Stain/Glaze-A and Modeling Fluid," which are physical materials used in dental procedures, not software. The performance studies also focus on physical and mechanical properties, biocompatibility, and shelf-life of these materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "make facings and veneers of customized denture crowns." This is a manufacturing process for a dental prosthetic, not a diagnostic test performed on a biological sample.
- Device Description: The components are materials used to build a dental restoration (porcelain powder, stains, modeling fluid). They are not reagents or instruments designed to analyze biological specimens.
- Performance Studies: The performance studies focus on the physical, mechanical, and biocompatibility properties of the material itself, not on the accuracy or reliability of a diagnostic result.
- Anatomical Site: While the final product is used in the patient's oral cavity, the device itself (the powder and fluids) is used outside the body to create the restoration. IVDs are typically used to test samples from the body.
In summary, this device is a dental material used in the fabrication of a medical device (a denture crown), not a diagnostic tool used to obtain information about a patient's health status from a biological sample.
N/A
Intended Use / Indications for Use
Porcelain Powder can be used to make facings and veneers of customized denture crowns.It is suitable for adults over 18 years old.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
This product includes Porcelain Powder, Stain/Glaze, Stain/Glaze-A and Modeling Fluid.
Enamel/ Modifier is Enamel porcelain, its function is to make adjusted porcelain powder gently stacked in the incisal aimed at shape, and stack from incisal to the body, covering dentin porcelain:
Stain/Glaze and Stain/Glaze-A is Enamel layer, its function is to coat with a thin layer of glaze on the surface of the finishing porcelain crown to achieve the required color and gloss of natural teeth.
Modeling Fluid: A dental ceramic powder is mixed in order to shape or model it into its required form prior to firing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's oral cavity
Indicated Patient Age Range
adults over 18 years old.
Intended User / Care Setting
trained professional dentists in legitimate and legitimate customized denture.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
• Physical and mechanical properties of the subject device were evaluated according to FDA-recognized version ISO 6872:2015/AMD 1:2018 Dentistry - Ceramic materials.
Test items include uniformity, freedom from extraneous materials, mixing and compaction performance, flexural solubility, chemical solubility, radioactivity, coefficient of thermal expansion, glass transition temperature and shade and all tests were verified to meet acceptable criteria.
Biocompatibility Testing:
The nature of body contact of materials used in the design of the Porcelain Powder were classified as being Surface Devices in contact with mucosal membrane with a permanent 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:
- Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10
- Oral MucOsa Irritation ISO 10993-23
- Acute Systemic Toxicity- ISO 10993-11
- Pyrogen Test- ISO 10993-11
- Subchronic Systemic Toxicity ISO 10993-11
- Bacterial Reverse Mutation Test- ISO 10993-3
- TK Gene Mutation Test– ISO 10993-3
Sterility and Shelf-Life Testing:
The device is provided non-sterile.
From the shelf life testing report, the Porcelain Powder has a shelf life of 3 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
March 14, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Aidite (Qinhuangdao) Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lu Jiazui Rd., Pudong, 200120 China
Re: K250025
Trade/Device Name: Porcelain Powder (Enamel/ Modifier,Stain/Glaze-A,Modeling Fluid ) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 12, 2025 Received: March 13, 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.
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"
1
(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
2
Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., 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
3
Indications for Use
510(k) Number (if known) K250025
Device Name
Porcelain Powder (Enamel/ Modifier.Stain/Glaze.Stain/Glaze-A.Modeling Fluid)
Indications for Use (Describe)
Porcelain Powder can be used to make facings and veneers of customized denture crowns. It is suitable for adults over 18 years old.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
K250025
This summary is submitted in accordance with 21 CFR 807.92.
1.0 Submission Sponsor
| Name: | Aidite (Qinhuangdao) Technology Co., Ltd. |
|---|---|
| Address 1: | No.9 Dushan Road, Economic And Technological Development Zone, |
| Qinhuangdao City,066004 Hebei P.R.China; | |
| Address 2: | No.56 Tianchi Road, Economic And Technological Development |
| Zone,Qinhuangdao City,066004 Hebei P.R. China | |
| Contact: | Mr. Ye Zhanfu |
| Tel: | +86 335 8587898 |
| 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: Mar.12md ,2025
2.0 Device Information
| Trade name: | Porcelain Powder |
|---|---|
| Common name: | Dental Porcelain Powder |
| Classification name: | Porcelain Powder For Clinical Use |
| Model: | Enamel/ Modifier, Stain/Glaze, Stain/Glaze-A, Modeling Fluid |
| Production code: | EIH |
| Regulation number: | 21 CFR 872.6660 |
| Classification: | Class II |
| Panel: | Dental |
3.0 Identification of Predicate Device and Reference Device
Predicate Device:
5
K232676 510(k) Number:
Trade/Product Name: Dental Porcelain Powder Manufacturer: Chengdu Besmile Medical Technology Co., Ltd.
4.0 Device Description
This product includes Porcelain Powder, Stain/Glaze, Stain/Glaze-A and Modeling Fluid.
Enamel/ Modifier is Enamel porcelain, its function is to make adjusted porcelain powder gently stacked in the incisal aimed at shape, and stack from incisal to the body, covering dentin porcelain:
Stain/Glaze and Stain/Glaze-A is Enamel layer, its function is to coat with a thin layer of glaze on the surface of the finishing porcelain crown to achieve the required color and gloss of natural teeth.
Modeling Fluid: A dental ceramic powder is mixed in order to shape or model it into its required form prior to firing
5.0 Indication for Use Statement
Porcelain Powder can be used to make facings and veneers of customized denture crowns.It is suitable for adults over 18 years old.
6.0 Non-clinical Test Conclusion
Bench Testing:
• Physical and mechanical properties of the subject device were evaluated according to FDA-recognized version ISO 6872:2015/AMD 1:2018 Dentistry - Ceramic materials.
Test items include uniformity, freedom from extraneous materials, mixing and compaction performance, flexural solubility, chemical solubility, radioactivity, coefficient of thermal expansion, glass transition temperature and shade and all tests were verified to meet acceptable criteria.
Biocompatibility Testing:
The nature of body contact of materials used in the design of the Porcelain Powder were classified as being Surface Devices in contact with mucosal membrane with a permanent 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:
- · Cytotoxicity ISO 10993-5
- · Sensitization ISO 10993-10
6
- · Oral MucOsa Irritation ISO 10993-23
- · Acute Systemic Toxicity- ISO 10993-11
- · Pyrogen Test- ISO 10993-11
- · Subchronic Systemic Toxicity ISO 10993-11
- · Bacterial Reverse Mutation Test- ISO 10993-3
- TK Gene Mutation Test– ISO 10993-3
Sterility and Shelf-Life Testing:
The device is provided non-sterile.
From the shelf life testing report, the Porcelain Powder has a shelf life of 3 years.
7.0 Summary of Clinical Test
Clinical testing was not required for this submission.
9.0 Technological Characteristics and Substantial Equivalence
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510(k) No. | K250025 | K232676 | -- |
| Product Name | Porcelain Powder | Dental Porcelain Powder | -- |
| Product Code | EIH | EIH | Same |
| Regulation No. | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Class | II | II | Same |
| Intended Use/ | |||
| Indication for | |||
| Use | Porcelain Powder can be used to | ||
| make facings and veneers of | |||
| customized denture crowns. It is | |||
| suitable for adults over 18 years | |||
| old. | This product is indicated for | ||
| use as a veneering material | |||
| for fixed prosthesis in crowns, | |||
| bridges. | Same | ||
| (Analysis 1) | |||
| Prescription Use | Yes | Yes | Same |
| Device Design | This product includes Porcelain | ||
| Powder, Stain/Glaze, | |||
| Stain/Glaze-A and Modeling | |||
| Fluid. | The product form is Porcelain | ||
| Powder, Stain/Glaze and | |||
| Blending liquid | Similar | ||
| Materials | This product includes Porcelain | ||
| Powder, Stain/Glaze, | |||
| Stain/Glaze-A and Modeling | |||
| Fluid. The porcelain powder is | This product includes | ||
| Porcelain Powder, | |||
| Stain/Glaze and Blending | |||
| liquid. The porcelain powder | Different | ||
| (Analysis 2) | |||
| composed of SiO2 (Silicon | |||
| Dioxide), Na2CO3 (Sodium | |||
| Carbonate), Li2CO3 (Lithium | |||
| Carbonate), H3BO3 (Boric Acid), | |||
| K2CO3 (Potassium Carbonate), | |||
| MgO (Magnesium Oxide), | |||
| CaCO3 (Calcium Carbonate), | |||
| ZrO2 (Zirconium Dioxide), | |||
| BaCO3 (Barium Carbonate), | |||
| Al2O3 (Aluminum Oxide), SnO2 | |||
| (Tin Dioxide). | |||
| The Modifier Model is in Powder | |||
| form with basic porcelain | |||
| powder; Modeling Fluid Model | |||
| are in Liquid form; Stain/Glaze | |||
| and Stain/Glaze-A are | |||
| provided in paste forms, | |||
| combining the components of | |||
| Modifier and Modeling Fluid, | |||
| along with various pigments, | |||
| and Stain/Glaze contains an | |||
| additional ingredient- NaF, | |||
| compared to Stain/Glaze-A. | is composed of silica (SiO2), | ||
| alumina (Al2O3), potassium | |||
| oxide (K2O), sodium oxide | |||
| (Na2O), boron trioxide | |||
| (B2O3), calcium oxide (CaO), | |||
| barium oxide (BaO), zirconia | |||
| (ZrO2), zinc oxide (ZnO) , | |||
| lithium oxide (Li2O), tin oxide | |||
| (SnO2), magnesium oxide | |||
| (MgO), Yttrium oxide (Y2O3) | |||
| and terbium oxide (Tb2O3).. | |||
| The blending liquid is | |||
| composed of purified water, 1, | |||
| 3-butanediol and | |||
| diethanolamine. The | |||
| Stain/Glaze is composed of | |||
| the porcelain powder and the | |||
| blending liquid in accordance | |||
| with the mass ratio of 1:1 | |||
| Conditions of use | This product is used by trained | ||
| professional dentists in | |||
| legitimate and legitimate | |||
| customized denture. | Made by professional | ||
| technicians; This product is | |||
| used by trained professional | |||
| operators in legitimate and | |||
| legitimate customized denture | |||
| production institutions. | Same | ||
| Physicochemical | |||
| Properties | |||
| Per ISO 6872 | |||
| Dentistry – Dental | |||
| Ceramics | • Uniformity | ||
| • Freedom from Extraneous | |||
| Materials | |||
| • Mixing & Condensation | |||
| Properties (Class I Ceramics) | |||
| • Physical & Chemical | |||
| Properties | |||
| • Flexural Strength | |||
| • Linear Thermal Expansion | |||
| Coefficient | |||
| • Glass Transition Temperature | |||
| • Chemical Solubility | |||
| • Radioactivity | • Uniformity | ||
| • No foreign body | |||
| • Mixing & Condensation | |||
| Properties (Class I Ceramics) | |||
| • Physical & Chemical | |||
| Properties | |||
| • Flexural Strength | |||
| • Linear Thermal Expansion | |||
| Coefficient | |||
| • Glass Transition | |||
| Temperature | |||
| • Chemical Solubility | |||
| • Radioactivity | Same | ||
| Manufacturing | |||
| material | Glass ceramics | Glass ceramics | Same |
| Categorization by | |||
| nature of body | |||
| contact | Surface-contacting | ||
| medical | |||
| devices | |||
| Mucosal membranes | Surface-contacting | ||
| medical | |||
| devices | |||
| Mucosal membranes | Same | ||
| Categorization by | |||
| duration of contact | Long-term exposure contact time | ||
| exceeds 30d | Long-term | ||
| exposure contact | |||
| time exceeds 30d | Same | ||
| Applicable population | It is suitable for clinical patients | ||
| with denture defect or absence. | It is suitable for clinical patients | ||
| with denture defect or absence. | Same | ||
| Intended site | Patient's oral cavity | Patient's oral cavity | Same |
| 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 |
Table 1- Comparison of Technology Characteristics
7
8
Analysis:
The subject device is highly similar to the predicate device in terms of indications for use, design, material and processing.
The subject device is different from the predicate device in the following:
-
- The subject device and predicate device are substantially equivalent in terms of their intended use and indications for use:
- a) Both devices are intended for use as veneering materials for dental prosthetic restorations;
- b) The differences in wording between the two devices' indications for use do not reflect significant functional differences and do not introduce new questions of safety or effectiveness.
- c) The subject device's focus on facings and veneers for customized denture crowns is a subset of the broader application described for the predicate device (veneering material for crowns and bridges), there is no effect on the SE determination.
-
- The main ingredients are basically the same, and the candidate product has passed the biocompatibility test, and there are no new risks. Accordingly, it was concluded that the subject device is substantially equivalent in biocompatibility to the predicate device and the reference device.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device.