(28 days)
No
The 510(k) summary describes a material (dental glass ceramics blocks) used in dental restorations. The description focuses on the material composition, fabrication methods (hot press and CAD/CAM), and physical/mechanical properties. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a material (dental ceramic blocks) used to fabricate restorations (e.g., crowns, veneers), which are then used in a therapeutic way, but the blocks themselves do not directly provide therapy.
No
The device is a material (dental blocks) used for fabricating dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (blocks of ceramic material) used for fabricating dental restorations, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment.
- Device Description and Intended Use: The description clearly states that these blocks are used to fabricate dental restorations (veneers, crowns, etc.) that are placed in the mouth. They are a material used to create a physical structure, not to analyze biological samples.
- Lack of Biological Sample Analysis: There is no mention of analyzing any biological samples or providing diagnostic information based on such analysis.
This device is a dental material used for restorative purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/ CAM system.
Product codes
EIH
Device Description
Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. It has three model: HT,LT,ST, and totally 23 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2, C3,C4,D2,D3,D4,BL1,BL2,BL3,BL4, OM1, OM2 and OM3).
The performance of Dental Glass Ceramics Blocks conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-clinical Test Conclusion:
Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015/AMD 1:2018.
According to ISO 6872, the subject device is classified into the following:
Type II: All other forms of ceramic products.
Class 4: Monolithic ceramic for prostheses involving partially or fully covered substructure
Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
Summary of Clinical Test:
Clinical testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
July 12, 2024
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: K241715
Trade/Device Name: Dental Glass Ceramics Blocks (HT,LT,ST) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 14, 2024 Received: June 14, 2024
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"
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(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.
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).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adjodha. MChE, RAC, COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
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Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Dental Glass Ceramics Blocks (HT,LT,ST)
Indications for Use (Describe)
Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/ CAM system.
Type of Use (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
K241715
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: | Mr.Xu Jinzhong |
| 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: Jul.11,2024
2.0 Device Information
| Trade name: | Dental Glass Ceramics Blocks |
|---|---|
| Common name: | Dental Glass Ceramics |
| Classification name: | Porcelain powder for clinical use |
| 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:
K192231 510(k) Number: Trade/Product Name: Dental Glass Ceramics Blocks Aidite (Qinhuangdao) Technology Co., Ltd. Manufacturer:
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4.0 Device Description
Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. It has three model: HT,LT,ST, and totally 23 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2, C3,C4,D2,D3,D4,BL1,BL2,BL3,BL4, OM1, OM2 and OM3).
The performance of Dental Glass Ceramics Blocks conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials.
5.0 Indication for Use Statement
Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
6.0 Non-clinical Test Conclusion
Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015/AMD 1:2018.
According to ISO 6872, the subject device is classified into the following:
Type II: All other forms of ceramic products.
Class 4: Monolithic ceramic for prostheses involving partially or fully covered substructure
Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
7.0 Technological Characteristics
Principle of Operation
There is no change in the principle of operation as part of this submission from the previous clearance under K192231. The module still utilizes the same principles of operation for Dental Glass Ceramics Blocks governed by the following principles:
This product is made of silicon dioxide powder. It is made by high temperature melting, casting molding and high temperature nucleation. Professional dental restoration agencies make the forms fitting for patients by hot press moulding or CAD/CAM and
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install it into the place to be repaired after sintering. It gets excellent biocompatibility, aesthetic appearance after sintering.
8.0 Summary of Technological Characteristics of the Subject Device Compared to the Predicate Device
The subject device, Dental Glass Ceramics Blocks (Model: HT, LT, ST) and the predicate device Dental Glass Ceramics Blocks (Model: Hot press model and CAD/CAM model), have the following key similarities:
- · Both devices have the same intended use
- · Both devices have the same components and shades.
- · Both devices are indicated for the same patient population
- Both devices have the same principle of operation and mechanism of action
The modifications outlined in this subject device do not raise different questions of safety or effectiveness as demonstrated by performance testing using the same methods based on the FDA-recognized standard ISO 6872 that were utilized for the predicate device. Furthermore, these changes (1) do not affect the intended use or (2) alter the fundamental scientific technology of the device. The modified devices retain the same core technological characteristics as the predicate device.
9.0 Summary of Clinical Test
Clinical testing was not required for this submission.
10.0 Technological Characteristics and Substantial Equivalence
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
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| Table1 General Device Characteristics Comparison Table | |||
|---|---|---|---|
| Item | Subject Device | Predicate device | Remark |
| 510(k) No. | K241715 | K192231 | -- |
| Product Name | Dental Glass Ceramics Blocks | Dental Glass Ceramics Blocks | -- |
| Product Code | EIH | EIH | Same |
| Regulation No. | 872.6660 | 872.6660 | Same |
| Class | II | II | Same |
| Intended | |||
| Use/Indication | |||
| for Use | Dental Glass Ceramics Blocks | ||
| are indicated for fabricating | |||
| all-ceramic restorations such as | |||
| veneers, inlay/onlay, partial | |||
| crowns, anterior crowns, | |||
| posterior crowns, using the hot | |||
| press technique or CAD/CAM | |||
| system. | Dental Glass Ceramics Blocks | ||
| are indicated for fabricating | |||
| all-ceramic restorations such | |||
| as veneers, inlay/onlay, partial | |||
| crowns, anterior crowns, | |||
| posterior crowns, using the | |||
| hot press technique or | |||
| CAD/CAM system. | Same | ||
| Prescription Use | Yes | Yes | Same |
| Shapes | Blocks | Blocks | Same |
| Color | Various Color | Various Color | Same |
| Materials | SiO2, Li2O, K2O, Al2O3 and | ||
| other oxides | SiO2, Li2O, K2O, Al2O3 and | ||
| other oxides | Same | ||
| Dimension | Various | Various | Same |
| Processing at | |||
| Dental lab | Hot Press (Up. Press Series) | ||
| CAD/CAM (Up.CAD Series) | Hot Press (Up. Press Series) | ||
| CAD/CAM (Up.CAD Series) | Same | ||
| Model | HT, LT, ST | Hot press model, | |
| CAD/CAM model | Different* | ||
| Density(g/cm³) | |||
| Flexural | |||
| Strength(MPa) | |||
| Radioactive | |||
| (Bq·g⁻¹) | Meet the requirements of ISO | ||
| 6872:2018 | Meet the requirements of ISO | ||
| 6872:2018 | Same | ||
| Coefficient of | |||
| Thermal | |||
| Expansion (K-1) | |||
| Glass Transition | |||
| Temperature(°C) | |||
| Single Use | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Biocompatibility | Comply with ISO 10993-1:2018, | ||
| FDA Guidance | Comply with ISO 10993-1, | ||
| FDA Guidance | Same |
|--|
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Analysis*:
The subject device is same 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 model name has been changed for the subject device from the predicate device. Specifically, the predicate device's model name "Hot press model" has been changed to "HT model," and the model name "CAD/CAM model" has been changed to "LT model." It's just model name change, it has no effect on the substantial equivalence.
-
- Add a new model "ST" to the predicate device's "CAD/CAM model."
HT model is high translucency ceramic block. LT model is low translucency ceramic block. And the new model is super translucency ceramic block.
The only difference between ST and LT and HT is their aesthetic effect, while the rest of their performance remains unchanged.
Physical and mechanical property of the new model ST is performed per ISO 6872. Both the subject device and the predicate device have same physical/mechanical properties that met the requirements of ISO 6872.
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.