Who is the manufacturer of Dental Glass Ceramics?

Shenzhen Yurucheng Dental Materials Co., Ltd. filed the 510(k) submission for Dental Glass Ceramics (K233016).

What is the FDA product code for Dental Glass Ceramics?

EIH. It is classified under 21 CFR 872.6660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Dental Glass Ceramics?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Dental Glass Ceramics?

Amber Mill Q Series and Amber Mill Direct Series (K202952).

Who can help prepare an FDA 510(k) submission like Dental Glass Ceramics?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Dental Glass Ceramics

K233016 · Shenzhen Yurucheng Dental Materials Co., Ltd. · EIH · Dec 21, 2023 · Dental

Device Facts

Record ID	K233016
Device Name	Dental Glass Ceramics
Applicant	Shenzhen Yurucheng Dental Materials Co., Ltd.
Product Code	EIH · Dental
Decision Date	Dec 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6660
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.

Device Story

Dental Glass Ceramics are blocks composed of SiO2, Li2O, K2O, P2O5, Al2O3, and other oxides. Used by dental professionals in clinical settings to fabricate dental restorations (crowns, bridges, veneers, inlays, onlays). The device is processed via CAD/CAM or manual milling based on patient tooth anatomy. Provided non-sterile and intended for single use. The final restoration is placed by a dentist to restore tooth function and aesthetics. Performance conforms to ISO 6872 standards.

Clinical Evidence

No clinical data. Bench testing only, conducted per ISO 6872:2015 and ISO 10993 series. Testing included flexural strength (>300MPa), chemical solubility (<100 ug/cm2), radioactivity, thermal expansion, and glass transition temperature. Biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity, mutagenicity, and implantation) passed.

Technological Characteristics

Glass-ceramic block composed of SiO2, Li2O, K2O, P2O5, Al2O3. Fully crystallized state. Conforms to ISO 6872 (Type II, Class 3). Flexural strength >300MPa. Thermal expansion 10.5 ± 0.5 x 10^-6/°C. Glass transition temperature 500 ± 20 °C. Biocompatible per ISO 10993. Non-sterile, single-use.

Indications for Use

Indicated for use as inlays, onlays, veneer, partial crowns, and crowns in patients requiring dental restorations.

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

Amber Mill Q Series and Amber Mill Direct Series (K202952)

Related Devices

K242407 — Dental Glass Ceramics Blocks (HT, LT, MT) · Hunan Vsmile Biotechnology Co., Ltd. · Nov 13, 2024
K223194 — Glass Ceramic · Shenzhen Xiangtong Co., Ltd. · Feb 10, 2023
K241715 — Dental Glass Ceramics Blocks (HT,LT,ST) · Aidite (Qinhuangdao) Technology Co., Ltd. · Jul 12, 2024
K141727 — DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) · Liaoning Upcera Co., Ltd. · Dec 18, 2014
K242740 — Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) · Liaoning Rachcera Material Technology Co., Ltd. · Dec 5, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 acronym and name on the right. The Department of Health & Human Services logo is a stylized human figure. The FDA acronym is in blue, and the words "U.S. Food & Drug Administration" are in a slightly darker blue. December 21, 2023 Shenzhen Yurucheng Dental Materials Co., Ltd. % Shanfeng Jiang Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A. No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, Guangdong 510663 CHINA Re: K233016 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 22, 2023 Received: September 22, 2023 Dear Shanfeng Jiang: 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. {1}------------------------------------------------ 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). {2}------------------------------------------------ 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 {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K233016 Device Name Dental Glass Ceramics Indications for Use (Describe) Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {4}------------------------------------------------ #### Section 5 - 510(k) Summary #### K233016 Date of Summary Preparation: September 22, 2023 Date of Modification: December 21, 2023 #### 1. Submitter's Identifications Submitter's Name: Shenzhen Yurucheng Dental Materials Co., Ltd. 1. Address: 101-201, Building 4, No.1 Branch of Zhongcheng Life Science Park, No. 14 Zhongxing Road, Xiuxin Community, Kengzi Street Office, Pingshan District, Shenzhen, China. Zip Code: 518122 Contact Person: Hongfei Liao Contact Title: Registered Manager Contact E-mail Address: system(@yucera.com Tel: +86-755-84622395 #### 2. Correspondent's Identifications 2. Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: jiang13620586569@126.com Tel: +86-20-82329549 Fax: +86-20-82329549 #### 3. Name of the Device Device Classification Name: Powder, Porcelain Regulation Description: Porcelain powder for clinical use Trade Name: Dental Glass Ceramics Model: HT, LT, ML-HT, ML-LT 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: K202952 Amber Mill Q Series and Amber Mill Direct Series HASS CORP {5}------------------------------------------------ #### 5. Device Description Dental Glass Ceramics is composed of SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides. The block is intended to be processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method. The block is a single-use device and provided non-sterile. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials. ### 6. Intended Use of Device Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns. #### 7. Summary of Substantial Equivalence | | Proposed Device | Predicate device | Comparison | |------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510k Number | | K202952 | ------ | | Product Code | EIH | EIH | Same | | Classification Reg | 21 CFR 872.6660 | 21 CFR 872.6660 | Same | | Proprietary Name | Dental Glass Ceramics | Amber Mill Q Series and Amber Mill Direct Series | ------ | | Model: | HT, LT, ML-HT, ML-LT | ------ | ------ | | Manufacturer | Shenzhen Yurucheng Dental Materials Co., Ltd. | HASS CORP | ------ | | Indications for Use | Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns. | Once finalized into a suitable design, the Amber Mill Q Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial and crowns | Same | | | | crowns. | | | Materials | SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides | SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides | Same | | Crystallization State as Supplied | Fully crystallized | Fully crystallized | Same | | Device Design | Block | Block | Same | | Various | Various Translucency : High translucency(HT) Low translucency(LT) Medium Opacity(MO) | Various Translucency : High translucency(HT) Low translucency(LT) Medium Opacity(MO) | Same | | Shades | Shade : LT/ HT : 16 A-D and 4 Bleach MO : 5 MO0- MO4 | Shade : LT/ HT : 16 A-D and 4 Bleach MO : 5 MO0- MO4 | Same | | Single Use | Yes | Yes | Same | | Principle of Operation | Fabricating restorations using CAD/CAM system | Fabricating restorations using CAD/CAM system | Same | | Sterile | Non-sterile | Non-sterile | Same | | Type/Class per ISO 6872 | Type II , Class 3 | Type II , Class 3 | Same | | Flexural strength | > 300MPa (meeting the ISO6872 requirements) | > 300MPa (meeting the ISO6872 requirements) | Same | | Chemical solubility | < 100 ug / cm2 (meeting the ISO6872 requirements) | < 100 ug / cm2 (meeting the ISO6872 requirements) | Same | | Freedom from Extraneous Material | Shall be free from extraneous materials when assessed by visual inspection | Shall be free from extraneous materials when assessed by visual inspection | Same | | | (meeting ISO 6872 requirements) | (meeting ISO 6872 requirements) | | | Radioactivity | Activity concentration of uranium238 less than 1.0Bq g-1 (meeting the ISO6872 requirements) | Activity concentration of uranium238 less than 1.0Bq g-1 (meeting the ISO6872 requirements) | Same | | Linear of thermal expansion | $10.5 \pm 0.5 \times 10^{-6}/\degree C$ (meeting the ISO6872 requirements) | $11.5 \pm 0.5 \times 10^{-6}/\degree C$ (meeting the ISO6872 requirements) | Same | | Glass Transition Temperature | Tg:500 ± 20 °C (meeting ISO 6872 requirements) | Tg:500 ± 20 °C (meeting ISO 6872 requirements) | Same | | Biocompatibility | Non-toxic and biocompatible (Meeting the ISO 10993-3, 5, 10, 11 and 10993-6 Requirements) | Non-toxic and biocompatible (Meeting the ISO 10993-3, 5, 10, 6 and 10993-11 Requirements) | Same | | Discussion for Substantially Equivalent (SE) | The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices | | | | Item | Proposed device | Result | | | Cytotoxicity (ISO 10993-5:2009) | Under the conditions of this study, the test article was non cytotoxic for 2 h and was Mildly cytotoxic for 24 h in the filter diffusion method. Under the conditions of this study, the test article was Slight cytotoxic and was accepted in the agar diffusion method. Under the conditions of this study, the test article has no potential toxicity to L-929 cells. | Pass | | | Oral Mucosa Irritation (ISO 10993-10:2010) | The test article has no potential oral mucosa irritation in the Syrian hamsters. | Pass | | | Skin Sensitization Test (ISO 10993-10:2010) | The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | Pass | | | Subacute Systemic Toxicity Test (ISO 10993-11:2017) | There is no obvious histopathological difference in test group and control group. The structure of each organ in test group is normal, no abnormal histopathological changes in the table above was found. | Pass | | | Acute Systemic Toxicity (ISO 10993-11:2017) | The test article showed no evidence of causing acute system toxicity in the ICR mice. | Pass | | | In Vitro Mammalian Cell Gene Mutation Test (ISO 10993-3:2014) | Under the conditions of this study, the test article is considered non-mutagenic. | Pass | | | Bacterial Reverse Mutation Test (ISO 10993-3:2014) | Under the conditions of this study, the number of reverting colonies in the test article group is not equal to or greater than 2 times that of the spontaneous control, so the test article have no potential mutagenesis. | Pass | | | Muscle Implant 4 Weeks Test (ISO 10993-6:2016) | The test result showed that the test article did not induce local effects after implantation of biomaterials in rabbits under this condition. | Pass | | | Muscle Implant 13 Weeks Test (ISO 10993-6:2016) | The test result showed that the test article did not induce local effects after implantation of biomaterials in rabbits under this condition. | Pass | | #### Table 1 Comparison to Predicate Device {6}------------------------------------------------ # Shenzhen Yurucheng Dental Materials Co., Ltd. {7}------------------------------------------------ Shenzhen Yurucheng Dental Materials Co., Ltd. The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices. #### 8. Summary of Non-Clinical Testing Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Glass Ceramics met its specifications. All tests were verified to meet acceptance criteria. Test results on Product Code, Classification Reg, Indications for Use, Materials, Crystallization State as Supplied, Device Design, Shades , Single Use , Principle of Operation ,Sterile, Type/Class per ISO 6872, Flexural strength , Chemical solubility , Freedom from Extraneous Material , Radioactivity , Linear of thermal expansion , Biocompatibility and Glass Transition Temperature of the subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used. {8}------------------------------------------------ According to ISO 10993-1:2018, we evaluated and conducted the compatibility test for the proposed device. The following table shows the biocompatibility testing results. #### Table 2 Biocompatibility testing {9}------------------------------------------------ Note: Testing were Performed on Dental Glass Ceramics LT, with Pre-Shaded powder A4 (Due to the variety of Dental Glass Ceramics's models, LT-A4 with the most trace elements in type are selected as typical models for test) to cover the regular and Dental Glass Ceramics . ## 9. Clinical Test Conclusion No clinical study is included in this submission. #### 10. Conclusion: The conclusions drawn from the nonclinical tests demonstrate that subject device Dental Glass Ceramics performs as well as or better than the legally marketed predicate device K202952 Dental Glass Ceramics. Dental Glass Ceramics is substantial equivalent to the legally marketed predicate device K202952 Dental Glass Ceramics.