Dental Glass Ceramics

K232673 · Chengdu Besmile Medical Technology Co., Ltd. · EIH · Jan 23, 2024 · Dental

Device Facts

• Record ID: K232673
• Device Name: Dental Glass Ceramics
• Applicant: Chengdu Besmile Medical Technology Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Jan 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Dental Glass Ceramics are lithium disilicate glass ceramic blocks used for dental restorations. Material is processed via hot press technique or CAD/CAM systems. In CAD/CAM workflow: 3D dental scanner captures oral/model data; built-in software designs restoration; computer-controlled machining tools fabricate prosthesis; secondary crystallization at 800°C-840°C. In die-casting workflow: wax-up restoration designed via CAD/CAM; embedded and burned out in muffle furnace; ceramic block die-cast at 930°C-960°C. Finished restorations are placed by professional dentists. Device provides aesthetic tooth restoration similar to natural teeth.

Clinical Evidence

No clinical data. Bench testing only. Testing included material composition, dimensions, density (2.45g/cm³), flexural strength (393.8MPa), chemical solubility (29.7µg/cm²), radioactivity (<0.022Bq/g), linear expansion coefficient, and glass transition temperature. Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, intradermal reaction, systemic toxicity, genotoxicity) passed.

Technological Characteristics

Lithium disilicate glass ceramic; density ≥2.2g/cm³. Form factors: cylinders and cuboids. Processing: CAD/CAM or hot press (die-casting). Sintering/crystallization required. Non-sterile. Biocompatible per ISO 10993.

Indications for Use

Indicated for patients with denture defect or absence requiring all-ceramic restorations (veneers, inlays, onlays, partial/anterior/posterior crowns). Not suitable for molar restoration or prostheses involving four or more units.

Regulatory Classification

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.

Predicate Devices

• Dental lithium disilicate glass ceramic block (up. Press series and up. Cad series) (K141727)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>No.9,Sec.2, Shengwucheng North Rd., Chengdu Tianfu<br>International Bio-Town, Shuangliu District, Chengdu, Sichuan<br>610200, P.R.China |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Moushan Liu (Mr.)<br>Manager<br>Phone: [phone]<br>E-mail: [e-mail] |

#### 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 | Device<br>Characteristic | Subject Device | Predicate Device<br>(K141727) | Discussion |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------|------------|
| Trade Name of Device: | Dental lithium disilicate glass ceramic block (up. Press series<br>and up. Cad series) | Trade name | Dental Glass Ceramics | Dental lithium disilicate glass<br>ceramic block (up. Press series<br>and up. Cad series) | N/A |
| Regulation Number: | 21 CFR 872.6660 | Product code | EIH | EIH | Identical |
| Classification Name: | Powder, Porcelain | Regulation<br>Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| Regulatory Class | II | Regulatory<br>class | Class II | Class II | Identical |
| Product Code: | EIH | Manufacturer | Chengdu Besmile Medical<br>Technology Co., Ltd. | Liaoning Upcera Co., Ltd. | N/A |
| Intended Use | Dental Glass Ceramics are<br>indicated for fabricating<br>all-ceramic restorations such as<br>veneers, inlay/ onlay, partial<br>crowns, anterior crowns,<br>posterior crowns, using the hot<br>press technique or CAD/CAM<br>system. | Dental Lithium Disilicate Glass<br>Ceramic Blocks (Up. Press Series<br>and Up. CAD Series) are indicated<br>for fabricating all-ceramic<br>restorations such as veneers,<br>inlay/ onlay, partial crowns,<br>anterior crowns, posterior crowns,<br>using the hot press technique or<br>CAD/CAM system. | Identical | | |
| Structure<br>Composition | SiO2 , Al2O3 , Li2O , K2O , Na2O ,<br>CeO2 , Pr6O11 , Zr(Hf)O2 , P2O5 ,<br>CaO , MnO2 , Er2O3. | SiO2, Li2O, K2O, P2O5, Al2O3, B2O3,<br>and other oxides | Different<br>Comment 1 | | |
| Physical Form | Solid | Solid | Identical | | |
| Operation<br>Principle | This product is suitable for<br>CAD/CAM and die casting, and is<br>suitable for various grinding and<br>polishing equipment.<br>(1) CAD/CAM production<br>process:<br>① Digitally scan models,<br>wax-ups or oral preparations to<br>obtain 3D data sets;<br>② Software processing of 3D<br>data sets to design restorations;<br>③ Computer-controlled<br>machining tools complete the<br>fabrication (prosthesis) process; | This product is a material for<br>making all porcelain dentures, and<br>the method of computer aided<br>design/computer aided<br>manufacturing is used to make all<br>porcelain dentures. Use the<br>process to obtain dental module<br>data for scanning -CAD design<br>denture machining model -CAD<br>fabrication denture - denture<br>sintering and glazing - denture<br>finished product. | Different<br>Comment 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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| Device<br>Characteristic | Subject Device | Predicate Device<br>(K141727) | Discussion |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | ④ After 30min secondary<br>crystallization treatment at<br>800°C-840°C, the finished product<br>is made by professional<br>technicians, and finally used by<br>professional doctors for human<br>denture or tooth restoration.<br>(2) Die-casting production<br>process:<br>① Use CAD/CAM<br>computer-aided design to<br>process wax-up restorations;<br>② Embed the wax-up restoration<br>with embedding material;<br>③ Put the embedding ring into<br>the muffle furnace and heat it to<br>completely evaporate the<br>wax-type restoration;<br>④ Put the embedding ring into<br>the die-casting furnace, put it into<br>the ceramic block for die-casting,<br>the die-casting temperature is<br>930°C-960°C, and the time is<br>10min;<br>⑤ After the die-casting is cooled,<br>use sandblasting tools to clean<br>the embedded materials on the<br>surface of the restoration, and<br>then make the finished product<br>by professional technicians, and<br>finally use it for human dentures<br>or tooth restoration by<br>professional doctors.<br>⑥ This product is recommended<br>to use dental casting ceramic<br>quick embedding material, which<br>is suitable for all die casting<br>furnaces and sandblasting tools<br>on the market. | | |
| Device<br>Characteristic | Subject Device | Predicate Device<br>(K141727) | Discussion |
| Device design | The product design is cylinder<br>and cuboid. | The product design is cylinder and<br>cuboid. | Identical |
| size | Cylinder<br>(Diameter × Height) mm:<br>12.5×11, 12.5×13, 12.5×15,<br>12.5×17, 11×8, 16×16, 98×10,<br>98×14, 98×18, 98×22, 95×14,<br>95×22, 100×12, 12×18, 20×20,<br>98×12, 98×16, 98×20, 98×25,<br>95×18, 100×10, 100×14<br>Cuboid<br>(Length × Width × Height) mm:<br>14×12×10, 15.5×13×11,<br>18.5×14.9×12.5, 18.5×16.9×12.5,<br>18.5×17.9×12.5, 72×44×42,<br>72×42×20, 72×42×18,<br>72×42×16, 72×42×14,<br>72×42×12, 93×75×16,<br>87×56×16, 75×38×16, 43×25×16, 58×29×16 | Cylinder<br>(Diameter × Height) mm:<br>13×10<br>Cuboid<br>(Length × Width × Height) mm:<br>18×15×13, 40×15×15 | Different<br>Comment 3 |
| Sterility | Non-sterile | Non-sterile | Identical |
| Materials | Lithium disilicate glass ceramics<br>Porcelain block density: ≥ 2.2g<br>/cm³. | Lithium disilicate glass ceramics<br>The density of the porcelain block<br>can be processed :2.3 ~ 2.6g/cm³. | Identical |
| Physicochemic<br>al properties | Flexural strength: The average<br>flexural strength of 10 samples<br>after sintering should be ≥300<br>MPa | The density of processed porcelain<br>after sintering :2.4 ~ 2.7g/cm³.<br>The biaxial bending strength of the<br>processed porcelain block after | Different<br>Comment 4 |
| Device<br>Characteristic | Subject Device | Predicate Device<br>(K141727) | Discussion |
| | Chemical solubility: After final<br>sintering should be < 100 µg/cm².<br>Radioactivity: The active<br>concentration of uranium-238<br>should be ≤1.0 Bq/g.<br>Linear expansion coefficient:<br>should be $(9.7±0.5) ×10^{-6} K^{-1}$ .<br>Glass transition<br>temperature :(530±20) °C. | sintering is greater than 300MPa.<br>Chemical solubility of machined<br>porcelain block after sintering: less<br>than 100ug/cm².<br>The activity of processed porcelain<br>after sintering: the active<br>concentration of U-238 is less than<br>1.0Bq/g.<br>Coefficient of thermal expansion<br>after sintering of machined<br>porcelain : $(8.5-11.0) ×10^{-6}K^{-1}$ . | |
| Categorization<br>by nature of<br>body contact | Surface-contacting medical<br>devices<br>Mucosal membranes | Surface-contacting medical<br>devices<br>Mucosal membranes | Identical |
| Categorization<br>by duration of<br>contact | Long-term exposure | Long-term exposure | Identical |
| Applicable<br>population | It is suitable for clinical patients<br>with denture defect or absence. | It is suitable for clinical patients<br>with denture defect or absence. | Identical |
| Intended user | The product is used by trained<br>professional dentists in legal and<br>formal custom denture<br>manufacturing facilities. | It is made by professional<br>technicians and used by<br>professional doctors. | Identical |
| Clinical effect | The aesthetic restoration effect is<br>similar to the color and<br>appearance of natural teeth | The aesthetic restoration effect is<br>similar to the color and<br>appearance 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 | Acceptance<br>Criteria | Test result | Conclusion |
|-----|-----------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 1 | Physical Testing of Dental Glass Ceramics | | | | |
| 1.1 | Material<br>composition<br>content | Ingredient | Product<br>technical<br>requirements | Silicon dioxide (SiO2):<br>68.32% | Pass |
| | | Content (%) | | Alumina (Al2O3) :<br>4.02% | |
| | | Silicon dioxide (SiO2) 60~75 | | Lithium oxide (Li2O):<br>13.09% | |
| | | Aluminum oxide (Al2O3) 2~7 | | Potassium oxide + sodium<br>oxide (K2O+Na2O):<br>3.02% | |
| | | Lithium oxide (Li2O) 5~17 | | Phosphorus<br>pentoxide(P2O5):<br>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<br>(Zr (Hf) $O_2$ ) | 0.5 ~ 6 | Praseodymium oxide<br>( $Pr_6O_{11}$ ): | |
| | | Praseodymium<br>oxide ( $Pr_6O_{11}$ ) | ≤5 | 1.66% | |
| | | Cerium dioxide<br>( $CeO_2$ ) | ≤2.5 | Cerium dioxide ( $CeO_2$ ):<br>1.61% | |
| | | Erbium<br>oxide( $Er_2O_3$ ) | ≤4.5 | Erbium oxide( $Er_2O_3$ ):<br>1.59% | |
| | | Manganese<br>dioxide ( $MnO_2$ ) | ≤1 | Manganese dioxide<br>( $MnO_2$ ):<br>< 0.01% | |
| | | Calcium oxide<br>(CaO) | ≤1.5 | Calcium oxide (CaO):<br>0.78% | |
| | | Other oxides | ≤2 | Other oxides:<br>0.51% | |
| 1.2 | Size<br>requirement | The deviation of specifications<br>and dimensions shall be ± 0.5 mm. | | Length:<br>18.47mm, 18.43mm,<br>18.41mm, 18.42mm,<br>18.48mm.<br>Width:<br>14.84mm, 14.87mm,<br>14.82mm, 14.85mm,<br>14.82mm.<br>Height:<br>12.36mm, 12.47mm,<br>12.41mm, 12.39mm,<br>12.38mm | Pass |
| 1.3 | Appearance | No spot cracks and foreign bodies<br>were visible on the surface | | No spotted cracks and<br>foreign bodies were found<br>on the surface of the<br>sample | Pass |
| 1.4 | Porcelain block<br>density | Should be ≥2.2g/cm3 | | 2.45g/cm3 | Pass |
| 1.5 | Flexural strength | The average flexural strength of<br>10 samples after sintering should<br>be ≥300MPa | | 393.8MPa | Pass |
| 1.6 | Chemical<br>solubility | Should the final sintering be<br><100ug/cm2 | | 29.7µg/cm2 | Pass |
| 1.7 | Radioactivity | The active concentration of<br>uranium-238 should be ≤1.0Bq/g | | <0.022Bq/g | Pass |
| 1.8 | Linear<br>expansion<br>coefficient | It should be $(9.7\pm0.5) \times 10^{-6}K^{-1}$ | | $9.4\times10^{-6}K^{-1}$ | Pass |
| 1.9 | Glass transition<br>temperature | It should be $(530\pm20)$ °C | | 541.3°C | Pass |
| 2 | Biocompatibility Testing | | | | |
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxi<br>c | Pass | Pass |
| 2.2 | Delayed<br>hypersensitivity | ISO 10993-10:2010 | Non-Delayed<br>hypersensitiv<br>ity | Pass | Pass |
| 2.3 | Intradermal<br>reaction | ISO 10993-10:2010 | Non-Intrader<br>mal reaction | Pass | Pass |
| 2.4 | Acute systemic<br>toxicity | ISO 10993-11:2017 | Non-Acute<br>systemic<br>toxicity | Pass | Pass |
| 2.5 | Subchronic<br>systemic toxicity | ISO 10993-11:2017 | Non-Acute<br>systemic<br>toxicity | Pass | Pass |
| 2.6 | Genotoxicity | ISO 10993-3:2014 | Non-genotoxi<br>city | 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.