(130 days)
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.
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 SiO2, Li2O, K2O, Al2O3, P2O5, 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.
This document is a 510(k) summary for a dental material, not an AI/ML medical device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable.
The document describes the acceptance criteria for the Dental Lithium Disilicate Glass-Ceramic device and the non-clinical testing performed to demonstrate its compliance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table (Table 1) that includes several parameters which act as acceptance criteria derived primarily from the ISO 6872:2015 standard for ceramic materials. The "New Device" column shows the reported device performance.
| Parameters | Acceptance Criteria (New Device Performance) | Predicate Device A (IPS E.MAX CAD) | Predicate Device B (Glass Ceramics) | Remarks (Comparison to Predicates) |
|---|---|---|---|---|
| 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 | For preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges. | Similar indications, specifically for CAD/CAM machinable glass ceramic. | Similar indications, including veneers, inlay/onlay, partial crowns, anterior/posterior crowns (hot press or CAD/CAM). | Similar |
| Material | $SiO_2$, $Li_2O$, $K_2O$, $Al_2O_3$, $P_2O_5$, $ZrO_2$ and other oxides | $SiO_2$, $Li_2O$, $K_2O$, $P_2O_5$, $ZrO_2$, $ZnO$ and other oxides | $SiO_2$, $Li_2O$, $K_2O$, $Al_2O_3$ and other oxides | Similar |
| Environment of use | Prescription Use | Prescription Use | Prescription Use | Same |
| Design | Cuboid, Cylinder | Block | Block | Similar |
| Color (Translucency) | HT, MT, LT, MO, HO | HT, LT, MO | Various (not publicly available for Predicate B) | Similar (New device offers more options than Predicate A) |
| Color (Shades) | HT/MT/LT: 16 A-D and 4 Bleach; MO: 5 MO 0 – MO 4; HO: 3 HO 0– HO 2 | HT/LT: 16 A-D and 4 Bleach; MO: 5 MO 0 – MO 4 | Not publicly available | Similar |
| Crystallization State | Cuboid: Partially crystallized; Cylinder: Fully crystallized | Partially crystallized | Not specified for Predicate B | Similar (Predicate A has only partially crystallized) |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Single Use | Yes | Yes | Yes | Same |
| Types, Class (ISO 6872:2015) | Type II, Class 3 | Type II, Class 3 | Type II, Class 2 | Similar (New device same as Predicate A, different from Predicate B) |
| Freedom from Extraneous materials | Free from extraneous materials | Free from extraneous materials | Not Reported | Same |
| Flexural Strength | $\geq300MPa$ | $\geq300MPa$ | $\geq100MPa$ | Same (As Predicate A, superior to Predicate B) |
| Linear thermal Expansion 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 Temperature | $495±20°C$ | Not Reported | $520±20°C$ | Similar |
| Chemical Solubility | $< 100µg/cm^2$ | $< 100µg/cm^2$ | Not Reported | Same |
| Shrinkage factor | Length: 1.0011, Width: 1.0018, Height: 1.0036 | Not Reported | $< 100µg/cm^2$ (This appears to be a typo/misalignment in the table, as Shrinkage factor should not be µg/cm²) | Similar (to the extent it can be compared) |
| Radioactivity | Meets ISO 6872 requirements $\leq 1.0 Bq/g$ of $238U$ | Meets ISO 6872 requirements $\leq 1.0 Bq/g$ of $238U$ | Meets ISO 6872 requirements $\leq 1.0 Bq/g$ of $238U$ | Same |
| Biocompatibility | Conform to ISO 7405:2018 | Conform to ISO 10993-1 | Conform to ISO 10993 | Similar |
Study that proves the device meets the acceptance criteria:
The device's performance was proven through a series of bench tests and compliance with international standards. The Section "5. Non-clinical Testing Summary" states: "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: This standard directly specifies the physical and chemical properties (like flexural strength, chemical solubility, linear thermal expansion, radioactivity) that the "Dental Lithium Disilicate Glass-Ceramic" must meet for its classification (Type II, Class 3).
- 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.
These ISO 10993 series standards and ISO 7405 address the biocompatibility of the material.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For bench testing of materials, sample sizes are typically determined by the relevant ISO standards.
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 not applicable as the document is about a dental material, not an AI/ML diagnostic or image analysis device that requires expert-established ground truth. The "ground truth" for material properties is established through standardized laboratory measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for material bench testing.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" is defined by the physical, chemical, and biological properties as specified in the referenced ISO standards. For example, the "ground truth" for flexural strength is the value measured according to ISO 6872, and this measured value must meet or exceed the specified threshold ($\geq300MPa$). Similarly for chemical solubility, linear thermal expansion, and biocompatibility.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +86-0591-23507151 | |
| E-mail: sheshuiyu@brownmaterial.com | |
| 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: MDconsult@szhtw.com.cn | |
| Tel: 86-400-963-0755 | |
| 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 PredicateDevice | Reference Device | Remark |
|---|---|---|---|---|
| 510(k) Number | K230487 | K051705 | K222513 | --- |
| 510(k) Owner | Fuzhou Rick BrownBiomaterials CO.,LTD. | IVOCLARVIVADENT, INC. | Yilink (Tianjin)Biotechnology Co.,Ltd. | --- |
| Device Name | Dental LithiumDisilicateGlass-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 LithiumDisilicateGlass-Ceramic isavailable usingCAD/CAM and hotpressing techniques forthe preparation of fullceramic crowns, inlays,onlays, veneer and fullceramic 3-unit anteriorbridges. | e IPS e.max CAD is aCAD/CAMmachinable glassceramic based onlithium disilicate forthe preparation of fullceramic crowns, inlays,onlays, and fullceramic 3-unit anteriorbridges. | Glass Ceramics areindicated forfabricating all-ceramicrestorations such asveneers, inlay/onlay,partial crowns, anteriorcrowns, posteriorcrowns, using the hotpress technique orCAD/CAM system. | Similar |
| Material | SiO2, Li2O, K2O, Al2O3,P2O5, ZrO2 and otheroxides | SiO2, Li2O, K2O, P2O5,ZrO2, ZnO and otheroxides | SiO2, Li2O, K2O, Al2O3and other oxides | Similar |
| Environment ofuse | Prescription Use | Prescription Use | Prescription Use | Same |
| Design | Cuboid, Cylinder | Block | Block | Similar |
| Color | Translucency:High Translucency(HT) | Translucency:High Translucency(HT) | Various | Similar |
| Medium translucency (MT)Low Translucency (LT)Medium Opacity (MO)High Opacity (HO)Shades:HT/MT/LT: 16 A-D and 4 BleachMO: 5 MO 0 – MO 4HO: 3 HO 0– HO 2 | Low Translucency (LT)Medium Opacity (MO)Shades:HT/LT: 16 A-D and 4 BleachMO: 5 MO 0 – MO 4 | Not publicly available | Similar | |
| CrystallizationState as Supplied | Cuboid: Partially crystallized, final crystallization done by dentallaboratoryCylinder: Fully crystallized | Partially crystallized, final crystallization done by dentallaboratory | ||
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Single Use | Yes | Yes | Yes | Same |
| Types, Class(ISO 6872:2015) | Type II, Class 3 | Type II, Class 3 | Type II, Class 2 | Same |
| Freedom fromExtraneousmaterials | Free from extraneousmaterials | Free from extraneousmaterials | Not Reported | Same |
| FlexuralStrength | ≥300MPa | ≥300MPa | ≥100MPa | Same |
| Linear thermalExpansioncoefficient | $(9.8±0.5) x 10^{-6}/K$ | $(10.5±0.5) x 10^{-6}/K$ | $(11±0.5) x 10^{-6}/K$ | Similar |
| Glass TransitionTemperature | 495±20°C | Not Reported | 520±20°C | Similar |
| ChemicalSolubility | < 100µg/cm² | < 100µg/cm² | Not Reported | Same |
| Shrinkage factor | Length: 1.0011Width: 1.0018Height: 1.0036 | Not Reported | < 100µg/cm² | Similar |
| Radioactivity | Meets ISO 6872requirements≤ 1.0 Bq/g of 238U | Meets ISO 6872requirements≤ 1.0 Bq/g of 238U | Meets ISO 6872requirements≤ 1.0 Bq/g of 238U | Same |
| Biocompatibility | Conform to ISO 7405:2018 | Conform to ISO10993-1 | 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.
§ 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.