(327 days)
Dental Glass Ceramics Blocks are indicating 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 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, Al2Os and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
This document describes a 510(k) premarket notification for a dental device, specifically "Dental Glass Ceramics Blocks." It is not for a software-as-a-medical-device (SaMD) or an AI/ML-driven device. Thus, the questions about acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device (Dental Lithium Disilicate Glass Ceramic Block, K141727) through non-clinical bench testing and biocompatibility testing. The "acceptance criteria" in this context refer to the physical, chemical, and biocompatibility properties of the dental material, not the performance of an AI model.
Here's how to interpret the provided information in the context of the requested questions, noting the inapplicability of many of them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct "table of acceptance criteria and reported device performance" in the way one would expect for an AI/ML device (e.g., accuracy, sensitivity, specificity thresholds). Instead, it lists various characteristics and states whether the proposed device is "Same" or "Comparable" to the predicate, and whether it "Meet the requirements of ISO 6872:2015" for certain properties.
Here's a partial interpretation based on the "Substantial Equivalence Comparison" table and "Non-clinical Testing" section:
| Characteristic/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Product Code | Same as predicate (EIH) | EIH |
| Indications for Use | Same as predicate | Same as predicate |
| Materials | Comparable to predicate (acknowledging minor compositional differences but demonstrably equivalent physical/chemical properties) | SiO2, Li2O, K2O, Al2O3 and other oxides (Comparable to predicate) |
| Processing at Dental lab | Same as predicate (Hot Press or CAD/CAM) | Hot Press (Up. Press Series), CAD/CAM (Up.CAD Series) (Same as predicate) |
| Geometry | Similar to predicate (Blocks) | Blocks (Similar to predicate, which also includes disc and rod) |
| Dimension | Same as predicate (Various) | Various (Same as predicate) |
| Single use | Same as predicate (Yes) | Yes (Same as predicate) |
| Available color | Same as predicate (Various) | Various (Same as predicate) |
| Sterile | Same as predicate (Non-sterile) | Non-sterile (Same as predicate) |
| Density (g/cm³) | Meet the requirements of ISO 6872:2015 | Meet the requirements of ISO 6872:2015 |
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral Mucosa Irritation (ISO 10993-10:2010) | Not a primary oral mucosa irritant | Not a primary oral mucosa irritant under the conditions of the study |
| Sensitization (ISO 10993-10:2010) | Not a sensitizer | Not a sensitizer under the conditions of the study |
| Subacute and Subchronic Toxicity (ISO 10993-11:2006) | No subacute and subchronic toxic effects observed | No subacute and subchronic toxic effects observed |
| Genotoxicity (ISO 10993-3:2003) | No genotoxic effects observed | No genotoxic effects observed |
| Flexural Strength, Coefficient of Thermal Expansion, Glass Transition Temperature | Not explicitly stated "acceptance criteria" but implied they meet relevant standards based on "Bench testing was performed per ISO 6872:2015 and internal procedures...All tests were verified to meet acceptance criteria." | Results not detailed, but stated to meet acceptance criteria per ISO 6872:2015. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the bench testing. The testing would involve a specific number of material samples, but the document does not quantify this.
- Data Provenance: Not applicable in terms of "country of origin of the data" or "retrospective/prospective" studies as this is bench testing of physical materials, not clinical data collection. The manufacturer is Aidite (Qinhuangdao) Technology Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of material properties like density or tensile strength, is established by laboratory measurement and adherence to international standards (e.g., ISO 6872:2015), not by expert consensus in the way medical image interpretation would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication is a concept for human interpretation consistency or resolution of discrepancies, not for physical material property measurement.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical/Chemical Properties based on International Standards: The "ground truth" for this device's performance is objective measurement of its physical and chemical properties (e.g., density, flexural strength, biocompatibility) as defined by and tested according to international standards (e.g., ISO 6872:2015, ISO 10993 series).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device that requires a "training set."
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Image /page/0/Picture/0 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.
July 8, 2020
Aidite (Oinhuangdao) Technology Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou middle road , Nanshan District Shenzhen, Guangdong GD755, China
Re: K192231
Trade/Device Name: Dental Glass Ceramics Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 22, 2020 Received: June 8, 2020
Dear Christy Young:
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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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.
For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192231
Device Name Dental Glass Ceramics Blocks
Indications for Use (Describe)
Dental Glass Ceramics Blocks are indicating 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Product: Dental Glass Ceramics Block
510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Aidite (Qinhuangdao) Technology Co., Ltd. |
|---|---|
| Address | No.9 Dushan Road,Economic and Technological Development Zone,Qinhuangdao City China |
| Phone No. | +86 335 8587898 |
| Fax No. | +86 335 8587198 |
| Contact person | Zhang Wei |
| Date Prepared | May 28, 2019 |
| Website | www.zro2blocks.com |
- 1.2 Submission Correspondent
| Shenzhen Joyantech Consulting Co., Ltd | |
|---|---|
| Room 1122, International Mayors Communication Centre, No. 55 Shizhoumiddle road , Nanshan District, Shenzhen | |
| 卓远天成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Christy Young; Field Fu; |
| Contact person's e-mail | christy@cefda.com; cefda@foxmail.com |
| Website | http://www.cefda.com |
Device information 2.
.
| Trade name | Dental Glass Ceramics Blocks |
|---|---|
| Common name | Dental Glass Ceramics |
| Model | / |
| Classification | II |
| Classification name | Porcelain Powder for Clinical Use |
| Product code | EIH |
| Regulation No. | 872.6660 |
Legally Marketed Predicate Device 3.
| Trade Name | Dental Lithium Disilicate Glass Ceramic Block(Up.Press Series and Up.CAD Series) |
|---|---|
| 510(k) Number | K141727 |
| Product Code | EIH |
| Manufacturer | Liaoning Upcera Co., Ltd |
4. 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
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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, Al2Os and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
5. Intended Use/Indication for Use
Dental Glass Ceramics Blocks are indicating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
| Item | Proposed Device:Dental Glass Ceramics Blocks | Predicate Device:Dental Lithium DisilicateGlass CeramicBlock(Up.Press Series andUp. CAD Series)(K141727) | Comments |
|---|---|---|---|
| Product Code | EIH | EIH | Same |
| Indications forUse | Dental Glass Ceramics Blocksare indicated for fabricatingall-ceramic restorations such asveneers, inlay/onlay, partialcrowns, anterior crowns,posterior crowns, using the hotpress technique or CAD/CAMsystem. | Dental Lithium Disilicate GlassCeramic Blocks (Up. PressSeries and Up. CAD Series) areindicated for fabricatingallceramic restorations such asveneers, inlay/onlay, partialcrowns, anterior crowns,posterior crowns, using the hotpress technique or CAD/CAMsystem. | Same |
| Materials | SiO2, Li2O, K2O, Al2O3 and otheroxides | SiO2, Li2O, K2O, P2O5, Al2O3,B2O3, and other oxides | Comparable(Issue 1) |
| Processing atDental 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, disc and rod | Similar |
| Dimension | Various | Various | Same |
| Single use | Yes | Yes | Same |
| Available color | Various | Various | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Radioactivity(Bq · g-1) | |||
| Density(g/cm³) | Meet the requirements of ISO6872:2015 | Meet the requirements of ISO6872:2008 | Same |
| FlexuralStrength(MPa) | |||
| Coefficient ofThermalExpansion (K-1) | |||
| Glass TransitionTemperature (° C) | |||
| Cytotoxicity (ISO10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect | Same |
| Irritation OralMucosa Irritation(ISO10993-10:2010) | Not a primary oral mucosairritant under the conditions ofthe study | Not a primary oral mucosairritant under the conditions ofthe study | Same |
| Sensitization(ISO10993-10:2010) | Not a sensitizer under theconditions of the study | Not a sensitizer under theconditions of the study | Same |
| Subacute andSubchronicToxicity(ISO10993-11:2006) | No subacute and subchronictoxic effects observed | No subacute and subchronictoxic effects observed | Same |
| Genotoxicity( ISO10993-3:2003) | No genotoxic effects observed | No genotoxic effects observed | Same |
Substantial Equivalence Comparison 6.
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Product: Dental Glass Ceramics Block
lssue 1:
The subject device and the predicate devices might difference in compositions but all the devices have SiO2, Li2O, K2O and Al2O3 as major components. Despite this difference, the test results per ISO 6872 shows that the subject device is substantially equivalent to the predicate device in physical and chemical properties and meets the necessary requirements.
7. 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.
Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
8. Clinical testing
Clinical testing was not performed for the proposed device.
9. Conclusion
It has been shown in this 510(k) submission that Dental Glass Ceramics Blocks and its predicate devices have the similar indications for use, similar biocompatibility, and similar performance.
The difference between Dental Glass Ceramics Blocks and its predicate device do not raise any
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Product: Dental Glass Ceramics Block
question regarding its safety and effectiveness.
Dental Glass Ceramics Blocks, as designed and manufactured, is as safe and effective as its predicated device, and therefore is substantially equivalent as its predicate device.
§ 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.