(90 days)
Not Found
No
The summary describes a dental ceramic material processed using standard CAD/CAM or manual milling, with performance evaluated against ISO standards. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a material (dental glass ceramics) used to fabricate dental restorations, which replace or restore the function of damaged teeth. It is effectively a replacement part, not a device that itself provides a therapeutic effect.
No
The device is a dental restoration material (ceramic blocks) used to create inlays, onlays, veneers, partial crowns, and crowns. It does not perform any diagnostic function.
No
The device is a physical material (Dental Glass Ceramics) intended for use in dental restorations, not a software program.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for creating dental restorations (inlays, onlays, veneers, partial crowns, and crowns) for patients. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a block of ceramic material processed into dental restorations. It's a physical material used to replace or repair tooth structure.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies and Metrics: The performance studies and metrics focus on the physical and chemical properties of the ceramic material (flexural strength, solubility, etc.) and its biocompatibility, which are relevant to its use as a dental restoration material, not a diagnostic tool.
IVDs are devices used to perform tests on specimens derived from the human body to provide information for medical purposes. This dental ceramic material does not fit that description.
N/A
Intended Use / Indications for Use
Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Dental Glass Ceramics is composed of SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides. The block is intended to be processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method. The block is a single-use device and provided non-sterile. The performance of the dental blanks conforms to ISO 6872, 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 (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 met its specifications. All tests were verified to meet acceptance criteria. Test results on Product Code, Classification Reg, Indications for Use, Materials, Crystallization State as Supplied, Device Design, Shades , Single Use , Principle of Operation ,Sterile, Type/Class per ISO 6872, Flexural strength , Chemical solubility , Freedom from Extraneous Material , Radioactivity , Linear of thermal expansion , Biocompatibility and Glass Transition Temperature 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural strength: > 300MPa (meeting the ISO6872 requirements)
Chemical solubility:
§ 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
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December 21, 2023
Shenzhen Yurucheng Dental Materials Co., Ltd. % Shanfeng Jiang Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A. No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, Guangdong 510663 CHINA
Re: K233016
Trade/Device Name: Dental Glass Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 22, 2023 Received: September 22, 2023
Dear Shanfeng Jiang:
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.
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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 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 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.
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).
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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
510(k) Number (if known)
Device Name Dental Glass Ceramics
Indications for Use (Describe)
Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
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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Section 5 - 510(k) Summary
K233016
Date of Summary Preparation: September 22, 2023 Date of Modification: December 21, 2023
1. Submitter's Identifications
Submitter's Name: Shenzhen Yurucheng Dental Materials Co., Ltd. 1. Address: 101-201, Building 4, No.1 Branch of Zhongcheng Life Science Park, No. 14 Zhongxing Road, Xiuxin Community, Kengzi Street Office, Pingshan District, Shenzhen, China. Zip Code: 518122 Contact Person: Hongfei Liao Contact Title: Registered Manager Contact E-mail Address: system(@yucera.com Tel: +86-755-84622395
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 Model: HT, LT, ML-HT, ML-LT Regulation Medical Specialty: Dental Review Panel: Dental Product Code: EIH Regulation Number: 21 CFR 872.6660 Device Classification: Class II
4. The Predicate Devices
Predicate device: K202952 Amber Mill Q Series and Amber Mill Direct Series HASS CORP
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5. Device Description
Dental Glass Ceramics is composed of SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides. The block is intended to be processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method. The block is a single-use device and provided non-sterile.
The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
6. Intended Use of Device
Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays,
onlays, veneer, partial crowns and crowns.
7. Summary of Substantial Equivalence
| Proposed Device | Predicate device | Comparison | |
|---|---|---|---|
| 510k Number | K202952 | ------ | |
| Product Code | EIH | EIH | Same |
| Classification Reg | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Proprietary Name | Dental Glass | ||
| Ceramics | Amber Mill Q | ||
| Series and Amber | |||
| Mill Direct Series | ------ | ||
| Model: | HT, LT, ML-HT, | ||
| ML-LT | ------ | ------ | |
| Manufacturer | Shenzhen | ||
| Yurucheng Dental | |||
| Materials Co., Ltd. | HASS CORP | ------ | |
| Indications for | |||
| Use | Once finalized into | ||
| a suitable design, | |||
| the Dental Glass | |||
| Ceramics | |||
| are | |||
| indicated for use as | |||
| inlays, onlays, | |||
| veneer, partial | |||
| crowns and | |||
| crowns. | Once finalized into | ||
| a suitable design, | |||
| the Amber Mill Q | |||
| Series and Amber | |||
| Mill Direct Series | |||
| are indicated for | |||
| use as | |||
| inlays, onlays, | |||
| veneer, partial | |||
| and | |||
| crowns | Same | ||
| crowns. | |||
| Materials | SiO2, | ||
| Li2O, | |||
| K2O,P2O5,Al2O3 | |||
| and other oxides | SiO2, Li2O, | ||
| K2O,P2O5,Al2O3 | |||
| and other oxides | Same | ||
| Crystallization | |||
| State as Supplied | Fully crystallized | Fully crystallized | Same |
| Device Design | Block | Block | Same |
| Various | Various | ||
| Translucency : | |||
| High | |||
| translucency(HT) | |||
| Low | |||
| translucency(LT) | |||
| Medium | |||
| Opacity(MO) | Various | ||
| Translucency : | |||
| High | |||
| translucency(HT) | |||
| Low | |||
| translucency(LT) | |||
| Medium | |||
| Opacity(MO) | Same | ||
| Shades | Shade : | ||
| LT/ HT : 16 A-D | |||
| and 4 | |||
| Bleach | |||
| MO : 5 MO0- MO4 | Shade : | ||
| LT/ HT : 16 A-D | |||
| and 4 | |||
| Bleach | |||
| MO : 5 MO0- MO4 | Same | ||
| Single Use | Yes | Yes | Same |
| Principle of | |||
| Operation | Fabricating | ||
| restorations | |||
| using CAD/CAM | |||
| system | Fabricating | ||
| restorations | |||
| using CAD/CAM | |||
| system | Same | ||
| Sterile | Non-sterile | Non-sterile | Same |
| Type/Class per | |||
| ISO 6872 | Type II , Class 3 | Type II , Class 3 | Same |
| Flexural strength | > 300MPa | ||
| (meeting | |||
| the | |||
| ISO6872 | |||
| requirements) | > 300MPa | ||
| (meeting | |||
| the | |||
| ISO6872 | |||
| requirements) | Same | ||
| Chemical | |||
| solubility |