(91 days)
Not Found
No
The description focuses on the material composition and fabrication methods (hot press, CAD/CAM) of dental ceramic blocks, with no mention of AI or ML.
No
The device is a material (blocks) used to fabricate dental restorations, not a therapeutic device that directly treats or prevents disease.
No
Explanation: The device is a material (ceramic blocks) used for fabricating dental restorations, not for diagnosing medical conditions. It is used in the creation of a treatment, not in the identification of a problem.
No
The device description clearly states it is a physical product (blocks of ceramic material) used for fabricating dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental restorations (veneers, crowns, etc.) using hot press or CAD/CAM techniques. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a material (glass ceramics blocks) used to create dental prosthetics. It's a raw material for fabrication, not a device used to test or analyze biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
IVDs are typically used to perform tests on samples like blood, urine, tissue, etc., to detect diseases, conditions, or measure substances. This device is a material used to create a physical restoration.
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, using the hot press technique or CAD/CAM system.
Product codes (comma separated list FDA assigned to the subject device)
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, K2O, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
Notes: Dental Glass Ceramic Blocks are not suitable for three-unit restorations for molars and restorations with four or more units
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Glass Ceramics Blocks met its specifications. All tests were verified to meet acceptance criteria. Test results on radioactivity, dimension, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, glass transition temperature, sintering density and fracture toughness of the subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
According to ISO 10993-1:2018, we evaluated and conducted the compatibility test for the proposed device.
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
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 full name written in a smaller font next to it.
November 13, 2024
Hunan Vsmile Biotechnology Co., Ltd. Xiaomi Tang General Manager Room.1202-1203, Huanchuang Enterprise Square Building A4 No.2450 Yuelu West Avenue Hi-tech Development District Changsha, Hunan 410000 CHINA
Re: K242407
Trade/Device Name: Dental Glass Ceramics Blocks (HT, LT, MT) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 14, 2024 Received: August 14, 2024
Dear Xiaomi Tang:
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.
1
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 System (OS) 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 QS 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 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-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 medical devices and radiation-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-regulatory
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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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Dental Glass Ceramics Blocks (HT、LT、MT)
Indications for Use (Describe)
Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Section 5 - 510(k) Summary
510(k) Number : K242407 Date of Summary Preparation: November 12, 2024
1. Submitter's Identifications
Submitter's Name: Hunan Vsmile Biotechnology Co., Ltd. Address: Room.1202-1203, Huanchuang Enterprise Square, Building A4 No.2450 Yuelu West Avenue, Hi-tech Development District Changsha, China Zip Code: 410000 Contact Person: Xiaomi Tang Contact Title: General Manager Contact E-mail Address: info@dentalzirconiadisc.com Tel: +86-731-85682958
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: jiang13620586569@126.com Tel: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Device Classification Name: Powder, Porcelain Regulation Description: Porcelain powder for clinical use Trade Name: Dental Glass Ceramics Blocks Model: HT, LT, MT Regulation Medical Specialty: Dental Review Panel: Dental Product Code: EIH Regulation Number: 21 CFR 872.6660 Device Classification: Class II
4. The Predicate Devices
Primary Predicate device: K192231 Dental Glass Ceramics Blocks Aidite (Qinhuangdao) Technology Co., Ltd.
5. Device Description
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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, K2O, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
Notes: Dental Glass Ceramic Blocks are not suitable for three-unit restorations for molars and restorations with four or more units
6. 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.
7. Summary of Substantial Equivalence
Table 1 Comparison to Predicate Device
| Proposed Device | Predicate device | Comparison | |
|---|---|---|---|
| 510k Number | K192231 | ------ | |
| Product Code | EIH | EIH | Same |
| Proprietary Name | Dental Glass Ceramics Blocks | Dental Glass Ceramics Blocks | ------ |
| Model: | HT, LT, MT | ------ | ------ |
| Manufacturer | Hunan Vsmile Biotechnology Co., Ltd | Aidite (Qinhuangdao) Technology Co., Ltd. | ------ |
| Indications for Use | Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior | Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ partial onlay, anterior crowns, posterior crowns, | Same |
| crowns, using the | |||
| hot press technique | |||
| or CAD/CAM | |||
| or system. | crowns, using the | ||
| hot press technique | |||
| or CAD/CAM | |||
| or system. | |||
| Materials | SiO2, Li2O, K2O, | ||
| Al2O3 and other | |||
| oxides.( Refer to | |||
| the device | |||
| description) | SiO2, Li2O, K2O, | ||
| Al2O3 and other | |||
| oxides. (unknown) | Different | ||
| 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 | ||
| Geometry | Blocks | Blocks | Same |
| Dimension | Various | Various | Same |
| Single Use | Yes | Yes | Same |
| Available color | Various | Various | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Radioactivity | |||
| (Bq·g-1) | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Same | ||
| Density(g/cm3) | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Same | ||
| Flexural | |||
| Strength(MPa) | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Same | ||
| Coefficient of | |||
| Thermal | |||
| Expansion (K-1) | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Same | ||
| Glass Transition | |||
| Temperature(°C) | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Meet the | ||
| requirements of | |||
| ISO6872:2015 | Same | ||
| Cytotoxicity | |||
| (ISO10993-5:2009 | |||
| ) | No | ||
| cytotoxicity | |||
| effect | No | ||
| cytotoxicity | |||
| effect | Same | ||
| Irritation Oral | |||
| Mucosa | |||
| Irritation(ISO109 | |||
| 93-10:2010) | Not a primary oral | ||
| mucosa irritant | |||
| under the | |||
| conditions of the | |||
| study | Not a primary oral | ||
| mucosa irritant | |||
| under the | |||
| conditions of the | |||
| study | Same | ||
| 10993-10:2021) | under the | ||
| conditions of the | |||
| study | under the | ||
| conditions of the | |||
| study | |||
| Subacute and | |||
| Subchronic | |||
| Toxicity(ISO1099 | |||
| 3-11:2006) | No subacute and | ||
| subchronic | |||
| toxic | |||
| observed | No subacute and | ||
| subchronic | |||
| toxic | |||
| observed | Same | ||
| Genotoxicity | |||
| ( ISO10993-3:200 |
-
| No genotoxic
effects observed | No genotoxic
effects observed | Same |
| Discussion for
Substantially
Equivalent (SE) | The subject device and predicate device may have slight
differences in other components, but the main components
are SiO2, Li2O, K2O, and Al2O3, which are the same. Despite
these differences, the test results according to ISO 6872
show that the test device is essentially equivalent to the
equivalent device and meets the necessary requirements in
terms of physical and chemical properties. | | |
6
Hunan Vsmile Biotechnology Co., Ltd
7
Hunan Vsmile Biotechnology Co., Ltd
8. Summary of Non-Clinical Testing
Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Glass Ceramics Blocks met its specifications. All tests were verified to meet acceptance criteria. Test results on radioactivity, dimension, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, glass transition temperature, sintering density and fracture toughness of the subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
According to ISO 10993-1:2018, we evaluated and conducted the compatibility test for the proposed device.
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that subject device Dental Glass Ceramics Blocks is as safe and effective as the predicate device. Dental Glass Ceramics Blocks is substantial equivalent to the legally marketed predicate device K192231 Dental Glass Ceramics Blocks.