Dental Lithium Disilicate Glass-Ceramic

K230487 · Fuzhou Rick Brown Biomaterials Co., Ltd. · EIH · Jul 3, 2023 · Dental

Device Facts

• Record ID: K230487
• Device Name: Dental Lithium Disilicate Glass-Ceramic
• Applicant: Fuzhou Rick Brown Biomaterials Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Jul 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dental Lithium Disilicate Glass-Ceramic is available using CAD/CAM and hot pressing techniques for the preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges.

Device Story

Lithium disilicate glass-ceramic material supplied as cuboids or cylinders; fabricated via CAD/CAM or hot pressing techniques. Used by dental laboratories to create aesthetic dental restorations (crowns, inlays, onlays, veneers, 3-unit anterior bridges). Material composed of SiO2, Li2O, K2O, Al2O3, P2O5, ZrO2, and inorganic pigments. Cuboids are partially crystallized (final crystallization by lab); cylinders are fully crystallized. Non-sterile, single-use device. Restorations matched to natural tooth color via sintering. Benefits include aesthetic tooth replacement and structural restoration of damaged teeth.

Clinical Evidence

Bench testing only. Compliance verified against ISO 6872:2015 (ceramic materials) and ISO 7405:2018/ISO 10993 series (biocompatibility, cytotoxicity, genotoxicity, systemic toxicity, irritation, and local effects after implantation).

Technological Characteristics

Lithium disilicate glass-ceramic; composition includes SiO2, Li2O, K2O, Al2O3, P2O5, ZrO2. Form factor: cuboid or cylinder. Flexural strength ≥300MPa; chemical solubility <100µg/cm². Conforms to ISO 6872:2015 (Type II, Class 3). Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restorations including full ceramic crowns, inlays, onlays, veneers, and 3-unit anterior bridges.

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

• IPS E.MAX CAD (K051705)

Reference Devices

• Glass Ceramics (K222513)

Submission Summary (Full Text)

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July 3, 2023

Fuzhou Rick Brown Biomaterials Co., Ltd. % Sherry Kang Registrar Shenzhen Huatongwei International Inspection Co., Ltd. 1/F, Bldg 5, Hongfa Hi-tech Industrial Park Tianliao. Guangming Shenzhen, Guangdong 518107 China

Re: K230487

Trade/Device Name: Dental Lithium Disilicate Glass-Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 4, 2023 Received: April 4, 2023

Dear Sherry Kang:

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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542 of the Act); 21 CFR 1000-1050.

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 (QS) 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-

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 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).

Sincerely.

# Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., 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)

#### K230487

Device Name Dental Lithium Disilicate Glass-Ceramic

Indications for Use (Describe)

Dental Lithium Disilicate Glass-Ceramic is available using CAD/CAM and hot pressing techniques for the preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges.

X 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 [As required by 21 CFR 807.92]

| 1. Submission Information | |
|------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) Number: | K230487 |
| Date: | February 14th, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Fuzhou Rick Brown Biomaterials CO., LTD. |
| | The first and second floors of R&D Building, Jiecheng Industrial Park, |
| | No.36 Houshan Zhaishan, Nanyu Town, High-Tech District, Fuzhou, |
| | Fujian Province, China |
| | Tel: [phone] |
| | E-mail: [e-mail] |
| Contactor: | Sherry Kang |
| | Shenzhen Huatongwei International Inspection Co.,Ltd. |
| | 1/F, Bldg5, Hongfa Hi-tech Industrial Park, Tianlia, Guangming, Shenzhen, |
| | Guangdong, 518107 China |
| | E-mail: [e-mail] |
| | Tel: [phone] |
| 2. Device Description | |
| Proprietary Name: | Dental Lithium Disilicate Glass-Ceramic |
| Classification Name: | Powder, Porcelain |
| Product Code: | EIH |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 872.6660 |
| Review Panel: | Dental |
| Indications for use: | Dental Lithium Disilicate Glass-Ceramic is available using CAD/CAM |
| | and hot pressing techniques for the preparation of full ceramic crowns, |
| | inlays, onlays, veneer and full ceramic 3-unit anterior bridges. |
| Device Description: | Dental Lithium Disilicate Glass-Ceramic is a lithium disilicate ceramic to |
| | be supplied in the form of cuboid and cylinder. Dental Lithium Disilicate |
| | Glass-Ceramic can be fabricated using CAD/CAM and hot pressing |
| | technologies. The device is a glass type material used for aesthetic |
| | purposes of full ceramic crowns, inlays, onlays, veneer and full ceramic |
| | 3-unit anterior bridges. |
| | The ceramics material is composed of $SiO_2$ , $Li_2O$ , $K_2O$ , $Al_2O_3$ , $P_2O_5$ , $ZrO_2$ |
| | and other oxides. It contains inorganic pigments. The inorganic pigments |
| | generate the color on the restorations, after sintering at dental labs, that |
| | matches natural color of patient's teeth. The performance of the device |
| | conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a |
| | single-use device, and provided non-sterile. |

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## 3. Predicate Device Identification

| Primary Predicate Device: | |
|---------------------------|------------------------------------------|
| 510(k) Number: | K051705 |
| Product Name: | IPS E.MAX CAD |
| Submitter/Manufacturer: | IVOCLAR VIVADENT, INC. |
| Reference Device: | |
| 510(k) Number: | K222513 |
| Product Name: | Glass Ceramics |
| Submitter/Manufacturer: | Yilink (Tianjin) Biotechnology Co., Ltd. |

## 4. Substantially Equivalent Comparison

| Table | 1 |
|-------|---|
| | |

| Parameters | New Device | Primary Predicate<br>Device | Reference Device | Remark |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) Number | K230487 | K051705 | K222513 | --- |
| 510(k) Owner | Fuzhou Rick Brown<br>Biomaterials CO.,<br>LTD. | IVOCLAR<br>VIVADENT, INC. | Yilink (Tianjin)<br>Biotechnology Co.,<br>Ltd. | --- |
| Device Name | Dental Lithium<br>Disilicate<br>Glass-Ceramic | IPS E.MAX CAD | Glass Ceramics | --- |
| Product Code | EIH | EIH | EIH | Same |
| Regulation No. | 21 CFR 872.6660 | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Class | 2 | 2 | 2 | Same |
| Intended use | Dental Lithium<br>Disilicate<br>Glass-Ceramic is<br>available using<br>CAD/CAM and hot<br>pressing techniques for<br>the preparation of full<br>ceramic crowns, inlays,<br>onlays, veneer and full<br>ceramic 3-unit anterior<br>bridges. | e IPS e.max CAD is a<br>CAD/CAM<br>machinable glass<br>ceramic based on<br>lithium disilicate for<br>the preparation of full<br>ceramic crowns, inlays,<br>onlays, and full<br>ceramic 3-unit anterior<br>bridges. | Glass Ceramics are<br>indicated for<br>fabricating all-ceramic<br>restorations such as<br>veneers, inlay/onlay,<br>partial crowns, anterior<br>crowns, posterior<br>crowns, using the hot<br>press technique or<br>CAD/CAM system. | Similar |
| Material | SiO2, Li2O, K2O, Al2O3,<br>P2O5, ZrO2 and other<br>oxides | SiO2, Li2O, K2O, P2O5,<br>ZrO2, ZnO and other<br>oxides | SiO2, Li2O, K2O, Al2O3<br>and other oxides | Similar |
| Environment of<br>use | Prescription Use | Prescription Use | Prescription Use | Same |
| Design | Cuboid, Cylinder | Block | Block | Similar |
| Color | Translucency:<br>High Translucency<br>(HT) | Translucency:<br>High Translucency<br>(HT) | Various | Similar |
| | Medium translucency (MT)<br>Low Translucency (LT)<br>Medium Opacity (MO)<br>High Opacity (HO)<br>Shades:<br>HT/MT/LT: 16 A-D and 4 Bleach<br>MO: 5 MO 0 – MO 4<br>HO: 3 HO 0– HO 2 | Low Translucency (LT)<br>Medium Opacity (MO)<br>Shades:<br>HT/LT: 16 A-D and 4 Bleach<br>MO: 5 MO 0 – MO 4 | Not publicly available | Similar |
| Crystallization<br>State as Supplied | Cuboid: Partially crystallized, final crystallization done by dental<br>laboratory<br>Cylinder: Fully crystallized | Partially crystallized, final crystallization done by dental<br>laboratory | | |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Single Use | Yes | Yes | Yes | Same |
| Types, Class<br>(ISO 6872:2015) | Type II, Class 3 | Type II, Class 3 | Type II, Class 2 | Same |
| Freedom from<br>Extraneous<br>materials | Free from extraneous<br>materials | Free from extraneous<br>materials | Not Reported | Same |
| Flexural<br>Strength | ≥300MPa | ≥300MPa | ≥100MPa | Same |
| Linear thermal<br>Expansion<br>coefficient | $(9.8±0.5) x 10^{-6}/K$ | $(10.5±0.5) x 10^{-6}/K$ | $(11±0.5) x 10^{-6}/K$ | Similar |
| Glass Transition<br>Temperature | 495±20°C | Not Reported | 520±20°C | Similar |
| Chemical<br>Solubility | < 100µg/cm² | < 100µg/cm² | Not Reported | Same |
| Shrinkage factor | Length: 1.0011<br>Width: 1.0018<br>Height: 1.0036 | Not Reported | < 100µg/cm² | Similar |
| Radioactivity | Meets ISO 6872<br>requirements<br>≤ 1.0 Bq/g of 238U | Meets ISO 6872<br>requirements<br>≤ 1.0 Bq/g of 238U | Meets ISO 6872<br>requirements<br>≤ 1.0 Bq/g of 238U | Same |
| Biocompatibility | Conform to ISO 7405:<br>2018 | Conform to ISO<br>10993-1 | Conform to ISO 10993 | Similar |

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The proposed device has the similar indication for use as the predicate devices as well as comparable technical and biocompatibility properties and characteristics, and the minor differences don't raise any additional questions for safety and effectiveness. Therefore, the proposed device is substantially equivalent to the predicate devices.

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## 5. Non-clinical Testing Summary

Bench tests were conducted to verify that the proposed device met all requirements. The test results demonstrated that the proposed device complies with the following standards:

- ISO 6872 Fourth edition 2015-06-01, Dentistry - Ceramic materials,

- ISO 7405 Third edition 2018-10 Corrected version 2018-12, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry,

- ISO 10993-3 Third edition 2014-10-1, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity,

- ISO 10993-5 Third edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity,

- ISO 10993-6 Third edition 2016-12-01, Biological evaluation of the medical devices - Part 6: Tests for Local Effects after Implantation,

- ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization,

- ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity,

- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.

## 6. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, the Dental Lithium Disilicate Glass-Ceramic, are as safe, as effective, and performs as well as the legally marketed predicate devices.