Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)

K242740 · Liaoning Rachcera Material Technology Co., Ltd. · EIH · Dec 5, 2024 · Dental

Device Facts

• Record ID: K242740
• Device Name: Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
• Applicant: Liaoning Rachcera Material Technology Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Dec 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

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 professionals in laboratory settings to create aesthetic dental restorations (crowns, inlays, onlays, veneers, 3-unit anterior bridges); material contains SiO2, Li2O, K2O, P2O5, Al2O3, ZrO2, and inorganic pigments; final crystallization performed by dental lab for cuboid form; provides natural tooth color matching; single-use; non-sterile; enhances patient aesthetics and dental function.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified against ISO 6872:2015 (ceramic materials) and ISO 7405:2018 (biocompatibility). Additional testing per ISO 10993 series (parts 3, 5, 6, 10, 11, 23) confirms safety regarding genotoxicity, cytotoxicity, local effects, sensitization, systemic toxicity, and irritation.

Technological Characteristics

Lithium disilicate glass-ceramic; composition: SiO2, Li2O, K2O, P2O5, Al2O3, ZrO2; form factor: cuboid/cylinder; flexural strength ≥300MPa; thermal expansion (9.8±0.5)×10^-6 K^-1; glass transition 495±20°C; chemical solubility <100 μg/cm²; conforms to ISO 6872:2015 (Type II, Class 3); non-sterile; single-use.

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

• Dental Lithium Disilicate Glass-Ceramic (K230487)

Submission Summary (Full Text)

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December 5, 2024

Liaoning Rachcera Material Technology Co.,Ltd. Liang Chen General Manager NO.31-1-5, Chang Qingnan Street, Hunnan New District Shenyang, Liaoning 110000 China

Re: K242740

Trade/Device Name: Dental Lithium Disilicate Glass Ceramic ( HT, ML-LT, MT, MQ, HO) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 11, 2024 Received: September 11, 2024

Dear Liang Chen:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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, 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

Submission Number (if known)

K242740

Device Name

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MO, HO)

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.

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 4 - 510(k) Summary K242740

### 1. Submitter's Identifications

Submitter's Name: Liaoning Rachcera Material Technology Co.,Ltd. Address: NO.31-1-5, Chang Qingnan Street, Hunnan New District, Shenyang Liaoning Province, China. Zip Code: 110000 Contact Person: Liang Chen Contact Title: General Manager Contact E-mail Address: [e-mail] Tel: [phone]

## 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 Citv. Guangdong. 510663. China ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: [e-mail] Tel: [phone] Fax: [phone]

### 3. Name of the Device

Device Classification Name: Powder, Porcelain Regulation Description: Porcelain powder for clinical use Trade Name: Dental Lithium Disilicate Glass Ceramic Model: HT, ML-HT, LT, ML-LT, MT, MO, HO 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: K230487 Dental Lithium Disilicate Glass-Ceramic Fuzhou Rick Brown Biomaterials Co., Ltd.

### 5. Device Description

Dental Lithium Disilicate Glass-Ceramic is a lithium disilicate ceramic to be supplied

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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 3unit anterior bridges.

The ceramics material is composed of SiO2, Li2O, K2O, P2O5, A12O3, ZrO2 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.

# 6. 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, veneer and full ceramic 3-unit anterior bridges.

# 7. Summary of Substantial Equivalence

| | Proposed Device | Predicate device | Comparison |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510k Number | K242740 | K230487 | -------- |
| Product Code | EIH | EIH | Same |
| Regulation No. | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Class | 2 | 2 | Same |
| Proprietary Name | Dental<br>Lithium<br>Disilicate<br>Glass<br>Ceramic | Dental<br>Lithium<br>Disilicate<br>Glass-Ceramic | -------- |
| Model: | HT, ML-HT, LT,<br>ML-LT, MT, MO,<br>HO | -------- | -------- |
| Manufacturer | Liaoning Rachcera<br>Material<br>Technology<br>Co.,Ltd. | Fuzhou Rick<br>Brown<br>Biomaterials Co.,<br>Ltd. | -------- |
| Indications for<br>Use | Dental Lithium<br>Disilicate Glass<br>Ceramic is<br>available using<br>CAD/CAM and hot<br>pressing techniques<br>for the preparation<br>of full ceramic | Dental Lithium<br>Disilicate<br>Glass-Ceramic is<br>available using<br>CAD/CAM and hot<br>pressing techniques<br>for the preparation<br>of | Same |
| | crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges. | full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges. | |
| Materials | SiO2, Li2O, K2O, P2O5, Al2O3, ZrO2 and other oxides. | SiO2, Li2O, K2O, P2O5, Al2O3, ZrO2 and other oxides. | Same |
| Environment of use | Prescription Use | Prescription Use | Same |
| Design | Cuboid, Cylinder | Cuboid, Cylinder | Same |
| Color | Translucency:<br>High Translucency (HT)<br>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:5MO 0 - MO 4<br>HO:3HO 0 - HO2 | Translucency:<br>High Translucency (HT)<br>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:5MO0 - MO4<br>HO:3HO0 - HO2 | Same |
| Crystallization State as Supplied | Cuboid: Partially crystallized, final crystallization done by dental laboratory<br>Cylinder: Fully crystallized | Cuboid: Partially crystallized, final crystallization done by dental laboratory<br>Cylinder: Fully crystallized | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Single Use | Yes | Yes | Same |
| Types, Class (ISO 6872:2015) | Type II, Class 3 | Type II, Class 3 | Same |
| Freedom from Extraneous materials | Free from extraneous materials | Free from extraneous materials | Same |
| Flexural<br>Strength | ≥300MPa | ≥300MPa | Same |
| Linear thermal<br>Expansion<br>coefficient | $(9.8±0.5)×10^{-6}K^{-1}$ | $(9.8±0.5)×10^{-6}K^{-1}$ | Same |
| Glass Transition<br>Temperature | 495±20°C | 495±20°C | Same |
| Chemical<br>Solubility | < 100 μ g/ cm² | < 100 μ g/ cm² | Same |
| Shrinkage factor | Length: 1.0011<br>Width: 1.0018<br>Height: 1.0036 | Length: 1.0011<br>Width: 1.0018<br>Height: 1.0036 | Same |
| Radioactivity | Meets ISO 6872<br>requirements<br>≤ 1.0 Bq/g of<br>238U | Meets ISO 6872<br>requirements<br>≤ 1.0 Bq/g of<br>238U | Same |
| Biocompatibility | Conform to ISO<br>7405:2018 | Conform to ISO<br>7405:2018 | Same |
| Discussion for<br>Substantially<br>Equivalent (SE) | The proposed device has same indications for use as the predicate device. The proposed device is similar to the predicate device in terms of design. | | |

Table 1 Comparison to Predicate Device

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Liaoning Rachcera Material Technology Co.,Ltd.

# 8. Summary of Non-Clinical Testing

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.

# 9. Clinical Test Conclusion

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No clinical study is included in this submission.

## 10. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that subject device Dental Lithium Disilicate Glass Ceramic is as safe and effective as the predicate device. Dental Lithium Disilicate Glass Ceramic is substantial equivalent to the legally marketed predicate device K230487 Dental Lithium Disilicate Glass-Ceramic.