(107 days)
Not Found
No
The device description and performance studies focus on the material properties and manufacturing process of zirconia blocks for dental prosthetics, with no mention of AI or ML for analysis, design, or manufacturing control. The mention of CAD/CAM refers to standard digital manufacturing techniques, not necessarily AI/ML-driven ones.
No.
The device is a raw material (zirconia blocks) used to manufacture dental prosthetics, which are considered medical devices, but the blocks themselves do not directly treat or prevent a disease or condition in a therapeutic manner. They are materials for fabrication, not a therapy.
No
The device description clearly states its purpose is for "manufacturing a final dental appliance/prosthesis." It is a material used in the creation of dental restorations, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a "Zirconia ceramic block," which is a physical material used to manufacture dental prostheses. It is 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 and dental prostheses. 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 (zirconia ceramic block) used to fabricate dental appliances. It is not used to test or analyze a sample from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to gain information about a person's health status. This device is a material used in the creation of a dental prosthesis, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, for jacket facing, veneers. All Blocks are processed through dental laboratories or by dental professionals.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Zirconia ceramic block is made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental appliance/prosthesis (e.g., removable dentures, for jacket facing, veneers) for patient use. It is used to removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
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
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)
The non-clinical testing for Zirconia Block was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
- Physical Testing of Dental Glass Ceramics: Test results of ten samples for Chemical Composition (Y2O3+Zr(Hf)O2>99.5%), Flexural strength (Y2O3+Zr(Hf)O2>99.5%), Pre-sintering (≥2.75g/cm³), Post-sintering (≥6.00g/cm³), Sintering Shrinkage Rate (19%-22%), Pre-sintering (≤2000µg/cm²), Post-sintering (≤100µg/cm²), Linear thermal expansion-coeffici ent ($(10.5±0.5) × 10-6 K-1$), Scale out rate (The scaling factor falls within the range in between 1.210 and 1.260, and the deviation of the actual value from the nominal value should not be greater than 0.005), Appearance (Surface should be smooth and pore- free, uniform color, no local pigment separation phenomenon, no foreign body attached), and Size (error should be less than ± 0.2mm). All tests showed results within acceptable limits.
- Biocompatibility Testing: Tests performed according to ISO standards including Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2021), Irritation or intracutaneous reactivity (ISO 10993-23:2021), Acute systemic toxicity (ISO 10993-11:2017), Subacute toxicity (ISO 10993-11:2017), Sub chronic toxicity (ISO 10993-11:2017), and Genotoxicity (ISO 10993-3:2014). All tests passed, indicating non-cytotoxicity, non-sensitization, non-irritation, non-acute systemic toxicity, non-subacute toxicity, non-sub chronic toxicity, and non-genotoxicity.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2024
Hangzhou IVISTA Medical Devices Co., Ltd. Yao Cheng General Manager No. 7, Chunjiang Road, Qiaonan Development Zone Ningwei Town, Xiaoshan District Hangzhou, Zhejiang 311217 China
Re: K233125
Trade/Device Name: Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 15, 2023 Received: November 16, 2023
Dear Yao Cheng:
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.
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"
1
(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 OS 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).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
2
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) K233125
Device Name Zirconia Block
Indications for Use (Describe)
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, for jacket facing, 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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4
K233125 Section 3 510(k) Summary
l 510(k) Submitter
| Device Submitter: | Hangzhou IVISTA Medical Devices Co., Ltd.
No. 7, Chunjiang Road, Qiaonan Development Zone, Ningwei Town
Xiaoshan District. Hangzhou City 311217, Zhejiang Province, China |
| ------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Contact Person: Yao Cheng General Manager Phone: 86 13905009803 E-mail: cy2179@163.com
II Device
| Trade Name of Device: | Zirconia Block |
|---|---|
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Product Code: | EIH |
| Regulatory Class | II |
| Review Panel | Dental |
III Predicate Devices
| 510k Number | K192262 |
|---|---|
| Trade Name of Device: | Dental Zirconia Blocks |
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Regulatory Class | II |
| Product Code: | EIH |
IV Device Description
Zirconia ceramic block is made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental appliance/prosthesis (e.g., removable dentures, for jacket facing, veneers) for patient use. It is used to removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
V Indications for use
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures,for jacket facing,veneers.All Blocks are processed through dental laboratories or by dental professionals.
5
VI Technological Characteristics Comparison
| Device
Characteristic | Subject Device | Predicate Device
(K192262) | Discussion |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Trade name | Zirconia Block | Dental Zirconia Blocks | N/A |
| Regulation Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| Product Code | EIH | EIH | Identical |
| Manufacturer | Hangzhou IVISTA Medical
Devices Co., Ltd. | ARUMDENTISTRY Co., Ltd. | N/A |
| Device Classification | Powder, Porcelain | Powder, Porcelain | Identical |
| Intended Use | Zirconia Blocks are intended for
use for the production of artificial
teeth in fixed or removable
dentures,for jacket
facing,veneers.All Blocks are
processed through dental
laboratories or by dental
professionals. | Dental Zirconia Blocks are intended
for use for the production of artificial
teeth in fixed or removable
dentures,for jacket facing,veneers.All
Blocks are processed through dental
laboratories or by dental
professionals. | Identical |
| Prescription
Use | Yes | Yes | Identical |
| Shapes | Blocks | Blocks, disc | Different
Comment 1 |
| Color | White and Colour | White and Colour | same |
| Chemical
Composition
(Weight %) | ZrO2+HfO2+Y2O3 ≥99.0
ZrO2 >90
Y2O3 ≤9.5
Fe2O3 ≤0.5
Er2O3 ≤0.5
Other oxide / | White zirconia:
ZrO2+HfO2+Y2O3 ≥99.0
Y2O3 4.5~6.0
HfO2 ≤5
Al2O3 ≤0.5
Other oxide ≤0.5
Color zirconia:
ZrO2+HfO2+Y2O3 ≥98.0
Fe2O3 800Mpa | Identical |
| Solubilit | ≤100µg/cm² | 99.5% | | 99.9%,99.9%,99.9%,99.9%,99.9%,
99.9%,99.9%,99.9%,99.9%,99.9% |
| 1.2 | Chemical
Composition | Y2O3+Zr(Hf)O2>99.5% | | 912Mpa, 914Mpa, 910Mpa, 912Mpa,
915Mpa, 916Mpa, 906Mpa, 913Mpa,
913Mpa, 916Mpa |
| 1.3 | Pre-sintering | ≥2.75g/cm³ | Product
technical
requirements | 3.1 and 6.07g/cm³, 3.1 and 6.06g/
cm³, 3.1 and 6.06g/cm³, 3.1 and
6.07g/cm³, 3.1 and 6.06g/cm³, 3.1 and
6.07g/cm³, 3.1 and 6.06g/cm³, 3.11
and 6.07g/cm³, 3.1 and 6.06g/cm³,
3.12 and 6.06g/cm³ |
| 1.3 | Post-sintering | ≥6.00g/cm³ | | 6.07g/cm³, 3.1 and 6.06g/cm³, 3.1 and
6.07g/cm3, 3.1 and 6.06g/cm3, 3.11
and 6.07g/cm³, 3.1 and 6.06g/cm³ |
| 1.4 | Sintering
Shrinkage Rate | 19%-22% | | 20.53%, 20.51%, 20.49%,20.51%,
20.46%, 20.55%, 20.55%,20.51%,
20.5%, 20.51% |
| 1.5 | Pre-sintering | ≤2000µg/cm² | 0 and 0µg/cm², 0 and 0µg/cm², 0 and0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm² | |
| 1.5 | Post-sintering | ≤100µg/cm² | 0 and 0µg/cm², 0 and 0µg/cm², 0 and0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm² | |
| 1.6 | Linear thermal
expansion-coeffici
ent | $(10.5±0.5) × 10-6 K-1$ | 10.5×10-6 K-1, 10.6 ×10-6 K-1
10.3×10-6 K-1, 10.4 ×10-6 K-1
10.6×10-6 K-1, 10.3 ×10-6 K-1
10.5×10-6 K-1, 10.4 ×10-6 K-1
10.4×10-6 K-1,10.5×10-6 K-1 | |
| 1.7 | Scale out rate | The scaling factor falls within
the range in between 1.210
and 1.260, and the deviation
of the actural value from the
nominal value should not be
greater than 0.005. | 1.245, 1.250, 1.240, 1.242, 1.240,
1.246, 1.240, 1.248, 1.238, 1.249 | |
| 1.8 | Scale out rate | The scaling factor falls within
the range in between 1.210
and 1.260, and the deviation
of the actural value from the
nominal value should not be
greater than 0.005. | 1.245, 1.250, 1.240, 1.242, 1.240,
1.246, 1.240, 1.248, 1.238, 1.249 | |
| 1.9 | Appearance | Surface: surface should be
smooth and pore- free. | Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes,
Yes, Yes, Yes | |
| | | The color of zirconia
porcelain block used for
chip processing (initial
sintering state) should be
uniform, there should be no
local pigment separation
phenomenon, there should
be no foreign body
attached. | Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes,
Yes, Yes, Yes | |
| | | Size: the size error
should be less than ±
0.2mm. | +0.03mm, +0.03mm, +0.03mm,
+0.02mm, +0.02mm, +0.03mm,
+0.02mm, +0.02mm, +0.02mm, | |
| 1.10 | Packaging | The packing identification
should be distinct, and the
packing material should not
have obvious changes. | No obvious changes, no obvious
changes, no obvious changes, no
obvious changes, no obvious changes,
no obvious changes, no obvious
changes, no obvious changes, no
obvious changes, no obvious changes | |
| Biocompatibility Testing | | | | |
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-Cytotoxicity | Pass |
| 2.2 | Sensitization | ISO 10993-10:2021 | Non-Sensitization | Pass |
| 2.3 | Irritation or
intracutaneous
reactivity | ISO 10993-23:2021 | Non-Irritation or
intracutaneous
reactivity | Pass |
| 2.4 | Acute system
ictoxicity | ISO 10993-11:2017 | Non-Acute system
ictoxicity | Pass |
| 2.5 | Subacute toxicity | ISO 10993-11:2017 | Non-Subacute
toxicity | Pass |
| 2.6 | Sub chronic
toxicity | ISO 10993-11:2017 | Non-Sub chronic
toxicity | Pass |
| 2.7 | Genotoxicity | ISO 10993-3:2014 | Non-Genotoxicity | Pass |
Table VII-1: Performance testing was conducted on the subject device
8
9
VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Zirconia Block is as safe as effective, and performs as well as or better than the legally marketed device.
X Copy Statement
The Copy is an exact duplicate of the paper copy.
Signature of the applicant:
花遥
date of the submission:2023.12.11