(282 days)
No
The device description focuses on the material composition and manufacturing process (CAD/CAM) of the zirconia blocks, with no mention of AI or ML for analysis, processing, or decision-making.
No.
The device, Dental Zirconia Blocks, is intended for the production of artificial teeth, which are prosthetic replacements and not devices that deliver therapy or treatment for a disease.
No
The device is described as "Dental Zirconia Blocks" intended for the production of artificial teeth. Its function is to create dental restorations, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states the device is "Dental Zirconia Blocks," which are physical materials used for creating dental prosthetics. While CAD/CAM methods are mentioned for processing, the device itself is a physical block, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the production of artificial teeth in fixed or removable dentures, jacket crowns, facing, and veneers. This is a structural and restorative application within the body, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a material (zirconia blocks) used to fabricate dental prosthetics. It's a component for creating a medical device that will be placed in the patient's mouth.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples (like blood, urine, tissue, etc.) to diagnose a disease or condition.
- Standards: The standards mentioned (ISO 13356, ISO 6872, ISO 10993 series) are related to materials for surgical implants, dental ceramics, and biological evaluation of medical devices, not specifically to in vitro diagnostics.
In summary, this device is a material used in the manufacturing of dental prosthetics, which are medical devices intended for placement within the body. It does not perform any diagnostic function on biological samples.
N/A
Intended Use / Indications for Use
Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.
Product codes
EIH
Device Description
The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance.
They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3).
The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.
The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
The Dental Zirconia Blocks are provided as non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories or by dental professionals.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 6872:2015/Amd1:2018 Dentistry - Ceramic Materials
ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-6 Biological evaluation of the medical devices - Part 6: Tests for Local Effects after Implantation.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity
Performance Test Including:
Appearance Test,
Dimension Test,
Density Test,
Product composition
Flexural strength,
Linear thermal expansion-coefficient
Chemical solubility
Radioactivity of dental ceramic,
Fracture toughness
which comply with ISO 6872
Biocompatibility Comply with ISO 10993-1:2018, FDA Guidance, tests included cytotoxicity, oral mucosa irritation, skin sensitization, pyrogenicity, acute systemic toxicity, subacute toxicity, subchronic systemic toxicity, implantation effect and genotoxicity etc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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May 29, 2020
De Corematrix Co.Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 CHINA
Re: K192262
Trade/Device Name: Dental Zirconia Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 14, 2020 Received: March 2, 2020
Dear Boyle Wang:
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.
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
1
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 531-542 of the Act); 21 CFR 1000-1050.
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 medical devices and radiation-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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192262
Device Name Dental Zirconia Blocks
Indications for Use (Describe)
Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary, K192262
This summary of 510(k) substantial equivalence is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's Information
De Corematrix Co.Ltd. Name: Address: No.40 NanBeigang Road, HuKou County, JiuJiang, 332599 JiangXi,China Tel: 86-18379248893 Fax: 86-792-6322103 Contact: Kaixuan Liu Date of Preparation: May.28.2020
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Dental Zirconia Blocks Powder, Porcelain Common name: Classification name: Porcelain powder for clinical use
3.0 Classification
Production code: EIH Regulation number: 21 CFR 872.6660 Classification: Class II Panel: Dental
4.0 Identification of Predicate Device and Reference Device
Primary Predicate Device:
510(k) Number: K182068 Product Name: Erran Dental Zirconia Manufacturer: Hangzhou Erran Technology Co., Ltd.
4
Reference Device:
510(k) Number: K141724 Product Name: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Liaoning Upcera Company Limited.
5.0 Indication for Use Statement
Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. Blocks are processed through dental laboratories or by dental All professionals.
6.0 Device Description
The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance.
They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3).
The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.
The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
The Dental Zirconia Blocks are provided as non-sterile.
5
7.0 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 6872:2015/Amd1:2018 Dentistry - Ceramic Materials
ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-6 Biological evaluation of the medical devices - Part 6: Tests for Local Effects after Implantation.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity
8.0 Clinical Test Conclusion
Clinical testing was not required for this submission.
9.0 Technological Characteristics and Substantial Equivalence
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
6
| Item | Proposed device
K192262 | Primary Predicate
device K182068 | Reference device
K141724 | Remark |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product Name | Dental Zirconia Blocks | Erran Dental Zirconia | Upcera Dental Zirconia
Blank & Dental Zirconia
Pre-Shaded Blank | -- |
| Product Code | EIH | EIH | EIH | Same |
| Regulation No. | 872.6660 | 872.6660 | 872.6660 | Same |
| Class | II | II | II | Same |
| Intended Use | Dental Zirconia Blocks are
intended for use for the
production of artificial teeth
in fixed or removable
dentures, or for jacket
crowns, facing, and
veneers.
All Blocks are processed
through dental laboratories
or by dental professionals. | Erran Dental Zirconia
Blocks are indicated for
the production of artificial
teeth in fixed or
removable dentures, or
for jacket crowns, facing,
and veneers.
All Blocks are processed
thought dental
laboratories or by dental
professionals. | Upcera Dental Zirconia
Blank & Dental Zirconia
Pre-Shaded Blank are
used for dental
restorations using different
CAD/CAM or manual
milling machines.All
blanks are processed
thought dental laboratories
or by dental professionals. | Same
with the
Predicate
Device |
| Prescription
Use | Yes | Yes | Yes | Same |
| Shapes | Blocks, disc | Blocks, powder | Blocks, disc, and rod. | Same |
| Color | White and Colour | None | None,and pre-shaded | Analysis
1 |
Table 6-1 General Device Characteristics Comparison Table
7
| Chemical
Composition
(Weight %) | White zirconia: | Zirconia(ZrO2+HfO2+Y2O3
≥99.0) | Regular:
Zirconia(ZrO2+HfO2+Y2O3+
Al2O3≥99.0);
Pre-Shaded:
Zirconia(ZrO2+HfO2+Y2O3+
Al2O3≥98.0)
Inorganic pigments: Fe2O3
+Pr2O3+Er2O3 1500°C | Analysis
3 |
| Flexural
strength | > 800MPa | | > 800MPa | ≥900 MPa | Same
with the
Predicate
Device |
| Solubility |