(130 days)
No
The device description focuses on the material composition and fabrication techniques (CAD/CAM, hot pressing) of a dental ceramic. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are bench tests evaluating material properties and biocompatibility against standards.
No.
The device is a material used for dental restorations (full ceramic crowns, inlays, onlays, veneer, bridges) that replace missing or damaged tooth structure for aesthetic and functional purposes, rather than directly treating a disease or condition.
No
Explanation: The device is a material used for manufacturing dental restorations like crowns and veneers. It is a fabricated product, not a tool or system designed to identify or analyze medical conditions or diseases.
No
The device description clearly states it is a physical material (lithium disilicate ceramic in cuboid and cylinder form) used for dental restorations, not a software program.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the preparation of dental restorations (crowns, inlays, onlays, veneers, bridges) using CAD/CAM and hot pressing techniques. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a material (glass-ceramic) used for aesthetic and functional purposes in dental restorations. It is a physical material that is shaped and processed to create a final device.
- Lack of Diagnostic Purpose: There is no mention of this device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, or other bodily fluids or samples.
This device is a dental material used in the fabrication of dental prosthetics, which are considered medical devices, but not IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: ≥300MPa
Linear thermal Expansion coefficient: (9.8±0.5) x 10^-6/K
Glass Transition Temperature: 495±20°C
Chemical Solubility:
§ 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.
0
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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.
1
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
2
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. |
4
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
Device | Reference Device | Remark |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) Number | K230487 | K051705 | K222513 | --- |
| 510(k) Owner | Fuzhou Rick Brown
Biomaterials CO.,
LTD. | IVOCLAR
VIVADENT, INC. | Yilink (Tianjin)
Biotechnology Co.,
Ltd. | --- |
| Device Name | Dental Lithium
Disilicate
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
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. | e IPS e.max CAD is a
CAD/CAM
machinable glass
ceramic based on
lithium disilicate for
the preparation of full
ceramic crowns, inlays,
onlays, and full
ceramic 3-unit anterior
bridges. | 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. | Similar |
| Material | SiO2, Li2O, K2O, Al2O3,
P2O5, ZrO2 and other
oxides | SiO2, Li2O, K2O, P2O5,
ZrO2, ZnO and other
oxides | SiO2, Li2O, K2O, Al2O3
and other oxides | Similar |
| Environment of
use | 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 Bleach
MO: 5 MO 0 – MO 4
HO: 3 HO 0– HO 2 | Low Translucency (LT)
Medium Opacity (MO)
Shades:
HT/LT: 16 A-D and 4 Bleach
MO: 5 MO 0 – MO 4 | Not publicly available | Similar |
| Crystallization
State as Supplied | Cuboid: Partially crystallized, final crystallization done by dental
laboratory
Cylinder: Fully crystallized | Partially crystallized, final crystallization done by dental
laboratory | | |
| 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 from
Extraneous
materials | Free from extraneous
materials | Free from extraneous
materials | Not Reported | Same |
| Flexural
Strength | ≥300MPa | ≥300MPa | ≥100MPa | Same |
| 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 |