(144 days)
Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ onlay/ partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .
The provided document is a 510(k) Premarket Notification for a medical device called "Dental Glass Ceramics". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or developing an AI algorithm. Therefore, many of the requested categories for AI-based device studies are not applicable to this document.
Here's an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance
| ID# | Test | Method | Acceptance Criteria | Test Result | Conclusion |
|---|---|---|---|---|---|
| 1.1 Material Composition Content | |||||
| Silicon dioxide (SiO2) | Ingredient Content (%) | 60~75 | 68.32% | Pass | |
| Alumina (Al2O3) | Ingredient Content (%) | 2~7 | 4.02% | Pass | |
| Lithium oxide (Li2O) | Ingredient Content (%) | 5~17 | 13.09% | Pass | |
| Potassium oxide + sodium oxide (K2O+Na2O) | Ingredient Content (%) | 1~5 | 3.02% | Pass | |
| Phosphorus pentoxide (P2O5) | Ingredient Content (%) | 3~4 | 3.53% | Pass | |
| Zirconium (hafnium) dioxide (Zr (Hf) O2) | Ingredient Content (%) | 0.5 ~ 6 | 1.86% | Pass | |
| Praseodymium oxide (Pr6O11) | Ingredient Content (%) | ≤5 | 1.66% | Pass | |
| Cerium dioxide (CeO2) | Ingredient Content (%) | ≤2.5 | 1.61% | Pass | |
| Erbium oxide (Er2O3) | Ingredient Content (%) | ≤4.5 | 1.59% | Pass | |
| Manganese dioxide (MnO2) | Ingredient Content (%) | ≤1 | < 0.01% | Pass | |
| Calcium oxide (CaO) | Ingredient Content (%) | ≤1.5 | 0.78% | Pass | |
| Other oxides | Ingredient Content (%) | ≤2 | 0.51% | Pass | |
| 1.2 Size Requirement | The deviation of specifications and dimensions shall be ± 0.5 mm. | Length: 18.47mm, 18.43mm, 18.41mm, 18.42mm, 18.48mm. Width: 14.84mm, 14.87mm, 14.82mm, 14.85mm, 14.82mm. Height: 12.36mm, 12.47mm, 12.41mm, 12.39mm, 12.38mm | Pass | ||
| 1.3 Appearance | No spot cracks and foreign bodies were visible on the surface | No spotted cracks and foreign bodies were found on the surface of the sample | Pass | ||
| 1.4 Porcelain block density | Should be ≥2.2g/cm3 | 2.45g/cm3 | Pass | ||
| 1.5 Flexural strength | The average flexural strength of 10 samples after sintering should be ≥300MPa | 393.8MPa | Pass | ||
| 1.6 Chemical solubility | Should the final sintering be <100ug/cm2 | 29.7µg/cm2 | Pass | ||
| 1.7 Radioactivity | The active concentration of uranium-238 should be ≤1.0Bq/g | <0.022Bq/g | Pass | ||
| 1.8 Linear expansion coefficient | It should be $(9.7\pm0.5) \times 10^{-6}K^{-1}$ | $9.4\times10^{-6}K^{-1}$ | Pass | ||
| 1.9 Glass transition temperature | It should be $(530\pm20)$ °C | 541.3°C | Pass | ||
| 2 Biocompatibility Testing | |||||
| 2.1 Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass | Pass | |
| 2.2 Delayed hypersensitivity | ISO 10993-10:2010 | Non-Delayed hypersensitivity | Pass | Pass | |
| 2.3 Intradermal reaction | ISO 10993-10:2010 | Non-Intradermal reaction | Pass | Pass | |
| 2.4 Acute systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Pass | Pass | |
| 2.5 Subchronic systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Pass | Pass | |
| 2.6 Genotoxicity | ISO 10993-3:2014 | Non-genotoxicity | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For material composition, appearance, porcelain block density, radioactivity, linear expansion coefficient, and glass transition temperature, individual measurements are reported.
- For Flexural strength, the testing involved 10 samples.
- For Size requirement, 5 measurements each for length, width, and height are reported.
- For Biocompatibility testing (Cytotoxicity, Delayed hypersensitivity, Intradermal reaction, Acute systemic toxicity, Subchronic systemic toxicity, Genotoxicity), the document states "Pass" for each, implying sufficient samples were used to meet the ISO standards' requirements, but specific numbers are not provided.
- Data Provenance: The document does not explicitly state the country of origin for the test data. However, the submitter is Chengdu Besmile Medical Technology Co., Ltd. from Chengdu, Sichuan, China. The testing is described as "Non-clinical Testing (Bench)," indicating laboratory testing rather than data from human subjects. The data is retrospective in the sense that it's generated from manufactured samples for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is a non-clinical, material properties testing submission, not an AI or diagnostic device that requires expert-established ground truth. The acceptance criteria are based on recognized consensus standards (e.g., ISO 10993 series) and product technical requirements for dental materials. Therefore, no human experts were involved in establishing "ground truth" in the diagnostic sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of diagnostic outcomes.
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 a material science device, not an AI-based diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is a material science device, not an AI-based diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is defined by the acceptance criteria established by recognized consensus standards (e.g., ISO 10993 for biocompatibility) and internal product technical requirements for dental glass ceramics. These are objective, measurable physical, chemical, and biological properties, not human-interpreted diagnostic outcomes.
8. The sample size for the training set
Not applicable. This device is a material, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a material, not an AI model 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
January 23, 2024
Chengdu Besmile Medical Technology Co., Ltd. Moushan Liu Quality Manager No. 9. Sec. 2. Shengwucheng North Rd., Chengdu Tianfu International Bio-Town, Shuangliu District Chengdu, Sichuan 610200 CHINA
Re: K232673
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 1, 2023 Received: November 24, 2023
Dear Moushan Liu:
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) K232673
Device Name Dental Glass Ceramics
Indications for Use (Describe)
Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ 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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510(k) Summary — K232673
l 510(k) Submitter
| Device Submitter: | Chengdu Besmile Medical Technology Co., Ltd.No.9,Sec.2, Shengwucheng North Rd., Chengdu TianfuInternational Bio-Town, Shuangliu District, Chengdu, Sichuan610200, P.R.China |
|---|---|
| Contact Person: | Moushan Liu (Mr.)ManagerPhone: +86-28-88415850E-mail: 79802494@qq.com |
II Device
| Trade Name of Device: | Dental Glass Ceramics |
|---|---|
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Product Code: | EIH |
| Regulatory Class | II |
| Review Panel | Dental |
III Predicate Devices
| 510k Number | K141727 | DeviceCharacteristic | Subject Device | Predicate Device(K141727) | Discussion |
|---|---|---|---|---|---|
| Trade Name of Device: | Dental lithium disilicate glass ceramic block (up. Press seriesand up. Cad series) | Trade name | Dental Glass Ceramics | Dental lithium disilicate glassceramic block (up. Press seriesand up. Cad series) | N/A |
| Regulation Number: | 21 CFR 872.6660 | Product code | EIH | EIH | Identical |
| Classification Name: | Powder, Porcelain | RegulationNumber | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| Regulatory Class | II | Regulatoryclass | Class II | Class II | Identical |
| Product Code: | EIH | Manufacturer | Chengdu Besmile MedicalTechnology Co., Ltd. | Liaoning Upcera Co., Ltd. | N/A |
| Intended Use | Dental Glass Ceramics areindicated 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. Press Seriesand Up. CAD Series) are indicatedfor fabricating all-ceramicrestorations such as veneers,inlay/ onlay, partial crowns,anterior crowns, posterior crowns,using the hot press technique orCAD/CAM system. | Identical | ||
| StructureComposition | SiO2 , Al2O3 , Li2O , K2O , Na2O ,CeO2 , Pr6O11 , Zr(Hf)O2 , P2O5 ,CaO , MnO2 , Er2O3. | SiO2, Li2O, K2O, P2O5, Al2O3, B2O3,and other oxides | DifferentComment 1 | ||
| Physical Form | Solid | Solid | Identical | ||
| OperationPrinciple | This product is suitable forCAD/CAM and die casting, and issuitable for various grinding andpolishing equipment.(1) CAD/CAM productionprocess:① Digitally scan models,wax-ups or oral preparations toobtain 3D data sets;② Software processing of 3Ddata sets to design restorations;③ Computer-controlledmachining tools complete thefabrication (prosthesis) process; | This product is a material formaking all porcelain dentures, andthe method of computer aideddesign/computer aidedmanufacturing is used to make allporcelain dentures. Use theprocess to obtain dental moduledata for scanning -CAD designdenture machining model -CADfabrication denture - denturesintering and glazing - denturefinished product. | DifferentComment 2 |
IV Device Description
This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .
V Indications for use
Dental Glass Ceramics 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.
VI Technological Characteristics Comparison
VI-1: Comparison of Dental Glass Ceramics
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| DeviceCharacteristic | Subject Device | Predicate Device(K141727) | Discussion |
|---|---|---|---|
| ④ After 30min secondarycrystallization treatment at800°C-840°C, the finished productis made by professionaltechnicians, and finally used byprofessional doctors for humandenture or tooth restoration.(2) Die-casting productionprocess:① Use CAD/CAMcomputer-aided design toprocess wax-up restorations;② Embed the wax-up restorationwith embedding material;③ Put the embedding ring intothe muffle furnace and heat it tocompletely evaporate thewax-type restoration;④ Put the embedding ring intothe die-casting furnace, put it intothe ceramic block for die-casting,the die-casting temperature is930°C-960°C, and the time is10min;⑤ After the die-casting is cooled,use sandblasting tools to cleanthe embedded materials on thesurface of the restoration, andthen make the finished productby professional technicians, andfinally use it for human denturesor tooth restoration byprofessional doctors.⑥ This product is recommendedto use dental casting ceramicquick embedding material, whichis suitable for all die castingfurnaces and sandblasting toolson the market. | |||
| DeviceCharacteristic | Subject Device | Predicate Device(K141727) | Discussion |
| Device design | The product design is cylinderand cuboid. | The product design is cylinder andcuboid. | Identical |
| size | Cylinder(Diameter × Height) mm:12.5×11, 12.5×13, 12.5×15,12.5×17, 11×8, 16×16, 98×10,98×14, 98×18, 98×22, 95×14,95×22, 100×12, 12×18, 20×20,98×12, 98×16, 98×20, 98×25,95×18, 100×10, 100×14Cuboid(Length × Width × Height) mm:14×12×10, 15.5×13×11,18.5×14.9×12.5, 18.5×16.9×12.5,18.5×17.9×12.5, 72×44×42,72×42×20, 72×42×18,72×42×16, 72×42×14,72×42×12, 93×75×16,87×56×16, 75×38×16, 43×25×16, 58×29×16 | Cylinder(Diameter × Height) mm:13×10Cuboid(Length × Width × Height) mm:18×15×13, 40×15×15 | DifferentComment 3 |
| Sterility | Non-sterile | Non-sterile | Identical |
| Materials | Lithium disilicate glass ceramicsPorcelain block density: ≥ 2.2g/cm³. | Lithium disilicate glass ceramicsThe density of the porcelain blockcan be processed :2.3 ~ 2.6g/cm³. | Identical |
| Physicochemical properties | Flexural strength: The averageflexural strength of 10 samplesafter sintering should be ≥300MPa | The density of processed porcelainafter sintering :2.4 ~ 2.7g/cm³.The biaxial bending strength of theprocessed porcelain block after | DifferentComment 4 |
| DeviceCharacteristic | Subject Device | Predicate Device(K141727) | Discussion |
| Chemical solubility: After finalsintering should be < 100 µg/cm².Radioactivity: The activeconcentration of uranium-238should be ≤1.0 Bq/g.Linear expansion coefficient:should be $(9.7±0.5) ×10^{-6} K^{-1}$ .Glass transitiontemperature :(530±20) °C. | sintering is greater than 300MPa.Chemical solubility of machinedporcelain block after sintering: lessthan 100ug/cm².The activity of processed porcelainafter sintering: the activeconcentration of U-238 is less than1.0Bq/g.Coefficient of thermal expansionafter sintering of machinedporcelain : $(8.5-11.0) ×10^{-6}K^{-1}$ . | ||
| Categorizationby nature ofbody contact | Surface-contacting medicaldevicesMucosal membranes | Surface-contacting medicaldevicesMucosal membranes | Identical |
| Categorizationby duration ofcontact | Long-term exposure | Long-term exposure | Identical |
| Applicablepopulation | It is suitable for clinical patientswith denture defect or absence. | It is suitable for clinical patientswith denture defect or absence. | Identical |
| Intended user | The product is used by trainedprofessional dentists in legal andformal custom denturemanufacturing facilities. | It is made by professionaltechnicians and used byprofessional doctors. | Identical |
| Clinical effect | The aesthetic restoration effect issimilar to the color andappearance of natural teeth | The aesthetic restoration effect issimilar to the color andappearance of natural teeth | Identical |
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Comment 1
Our Device and Predicate Device have slight differences in composition, but they all take SiO2, Li2O, K2O, P2O5, Al2O3 as the main components. This does not affect the use of the product and does not create new risks.
Comment 2
The two descriptions are different, but the actual use and operation are the same. Stomatologists or dental clinic technicians use the scanning probe of a 3D dental scanner to scan models, wax patterns, or oral preparations to obtain 3D data of the patient's mouth. The scanned 3D data is analyzed and processed through the device's built-in software to obtain a 3D data model of the repaired denture. Professional technicians will then create
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dentures based on three-dimensional data models for professional doctors to use for human dentures or tooth restoration.3D oral scanners are commonly used Dental medical equipment, our company only produces Dental Glass Ceramics, do not sell 3D oral scanners.
Comment 3
The size of the product is different from the predicate device, and the different size only indicates that the content size of the product does not affect the performance and intended use of the product.
Comment 4
The porcelain block density requirements of Our Device are almost the same as those of the Predicate Device, and the actual value measured by us is within the requirements of the Predicate Device. This difference does not affect product safety and efficacy.
Our Device has the similar flexural strength, chemical solubility, and radioactivity as the Predicate Device.
The linear expansion coefficient of Our Device is within the range of Predicate Device and is more accurate than Predicate Device
VII Summary of Non-clinical Testing (Bench)
The non-clinical testing for Dental Glass Ceramics was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
| ID# | Test | Method | AcceptanceCriteria | Test result | Conclusion |
|---|---|---|---|---|---|
| 1 | Physical Testing of Dental Glass Ceramics | ||||
| 1.1 | Materialcompositioncontent | Ingredient | Producttechnicalrequirements | Silicon dioxide (SiO2):68.32% | Pass |
| Content (%) | Alumina (Al2O3) :4.02% | ||||
| Silicon dioxide (SiO2) 60~75 | Lithium oxide (Li2O):13.09% | ||||
| Aluminum oxide (Al2O3) 2~7 | Potassium oxide + sodiumoxide (K2O+Na2O):3.02% | ||||
| Lithium oxide (Li2O) 5~17 | Phosphoruspentoxide(P2O5):3.53% | ||||
| Potassium oxide + sodium oxide (K2O+Na2O) 1~5 | |||||
| Phosphorus 3~4 | Zirconium (hafnium) | ||||
| pentoxide( $P_2O_5$ ) | dioxide (Zr (Hf) $O_2$ ): | ||||
| Zirconium | 1.86% | ||||
| (hafnium) dioxide(Zr (Hf) $O_2$ ) | 0.5 ~ 6 | Praseodymium oxide( $Pr_6O_{11}$ ): | |||
| Praseodymiumoxide ( $Pr_6O_{11}$ ) | ≤5 | 1.66% | |||
| Cerium dioxide( $CeO_2$ ) | ≤2.5 | Cerium dioxide ( $CeO_2$ ):1.61% | |||
| Erbiumoxide( $Er_2O_3$ ) | ≤4.5 | Erbium oxide( $Er_2O_3$ ):1.59% | |||
| Manganesedioxide ( $MnO_2$ ) | ≤1 | Manganese dioxide( $MnO_2$ ):< 0.01% | |||
| Calcium oxide(CaO) | ≤1.5 | Calcium oxide (CaO):0.78% | |||
| Other oxides | ≤2 | Other oxides:0.51% | |||
| 1.2 | Sizerequirement | The deviation of specificationsand dimensions shall be ± 0.5 mm. | Length:18.47mm, 18.43mm,18.41mm, 18.42mm,18.48mm.Width:14.84mm, 14.87mm,14.82mm, 14.85mm,14.82mm.Height:12.36mm, 12.47mm,12.41mm, 12.39mm,12.38mm | Pass | |
| 1.3 | Appearance | No spot cracks and foreign bodieswere visible on the surface | No spotted cracks andforeign bodies were foundon the surface of thesample | Pass | |
| 1.4 | Porcelain blockdensity | Should be ≥2.2g/cm3 | 2.45g/cm3 | Pass | |
| 1.5 | Flexural strength | The average flexural strength of10 samples after sintering shouldbe ≥300MPa | 393.8MPa | Pass | |
| 1.6 | Chemicalsolubility | Should the final sintering be<100ug/cm2 | 29.7µg/cm2 | Pass | |
| 1.7 | Radioactivity | The active concentration ofuranium-238 should be ≤1.0Bq/g | <0.022Bq/g | Pass | |
| 1.8 | Linearexpansioncoefficient | It should be $(9.7\pm0.5) \times 10^{-6}K^{-1}$ | $9.4\times10^{-6}K^{-1}$ | Pass | |
| 1.9 | Glass transitiontemperature | It should be $(530\pm20)$ °C | 541.3°C | Pass | |
| 2 | Biocompatibility Testing | ||||
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass | Pass |
| 2.2 | Delayedhypersensitivity | ISO 10993-10:2010 | Non-Delayedhypersensitivity | Pass | Pass |
| 2.3 | Intradermalreaction | ISO 10993-10:2010 | Non-Intradermal reaction | Pass | Pass |
| 2.4 | Acute systemictoxicity | ISO 10993-11:2017 | Non-Acutesystemictoxicity | Pass | Pass |
| 2.5 | Subchronicsystemic toxicity | ISO 10993-11:2017 | Non-Acutesystemictoxicity | Pass | Pass |
| 2.6 | Genotoxicity | ISO 10993-3:2014 | Non-genotoxicity | Pass | Pass |
Table VII-1: Performance testing was conducted on the subject device.
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VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Dental Glass Ceramics is as safe as effective as the predicate device.
X Warnings
It is not suitable for prostheses involving molar restoration and for prostheses involving four or more units.
§ 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.