(115 days)
Not Found
No
The device is a material (zirconia blank) used in a CAD/CAM process, not the CAD/CAM system itself. The description focuses on the material's composition and properties, with no mention of AI or ML in its function or processing.
No.
The device is a zirconia blank used to create dental restorations, not a therapeutic device itself.
No
This device is a dental material (zirconia blanks) used for fabricating dental restorations such as crowns and bridges. Its intended use is for manufacturing, not for diagnosing any medical condition or disease.
No
The device is a physical material (zirconium oxide blanks) used in the manufacturing of dental restorations, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations (crowns, bridges, etc.) using CAD/CAM or manual milling. This is a manufacturing process for a medical device that will be implanted or placed in the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a material (zirconia blank) that is processed to create a dental restoration. It is not designed to analyze a biological sample for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of a biological sample.
The device is a material used in the creation of a dental prosthesis, which is a medical device, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Perfit ZR HT Dental Zirconia blank are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Product codes
EIH
Device Description
The Perfit ZR HT Dental Zirconia blank consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre-sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit ZR HT Dental Zirconia blank are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved. They are available in different models that differ in various specification and color. There are white zirconia products(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products and multi-layer(A1 SM, A2 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products.
The white zirconia is composed of Zr02+HfO2+Y2O3 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 +Pr203 +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 color 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.
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
Non-clinical Test Conclusion
The results of comparative study performed according to ISO 6872:2015 were indicated The performance of formed zirconia dental blanks meets the applicable requirements of the following FDA recognized standards:
- . ISO 6872: 2015- Dentistry-Ceramic Materials
- ISO 13356: 2015, Implant for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
- . ISO 10993-1:2018, Biological evaluation of medical devices — Part 5: Evaluation and testing within a risk management process
- . 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('Oral mucosa irritation) and skin sensitization.
- . ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity
Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015 and ISO 13356: 2015.
According to ISO 6872:2015, the subject device is classified into the following:
Type II: All other forms of ceramic products.
Class 5: Monolithic ceramic for prostheses involving partially or fully covered substructure for four or more units or fully covered substructure for prostheses involving four or mor units.
Bench test results allowed to conclude that Perfit ZR HT Dental Zirconia blank is substantially equivalent to the predicate devices for its intended use.
Clinical Test Conclusion
Clinical testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2021
Vatech acucera, Inc. Kyung Kwon Manager 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si, Gyeonggi-do SOUTH KOREA
Re: K203351
Trade/Device Name: Perfit ZR HT Dental Zirconia blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 12, 2021 Received: January 12, 2021
Dear Kyung Kwon:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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,
Michael E. Adjodha, M.ChE. Assistant 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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |
|---|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 | |
| Indications for Use | See PRA Statement below. | |
| 510(k) Number (if known) |
Device Name
Device Name
Perfit ZR HT Dental Zirconia blank
Indications for Use (Describe)
The Perfit ZR HT Dental Zirconia blank are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
| 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 FDA 3881 (7/17)
3
K203351
510(k) Summary
The following 510(k) summary is being submitted as required by 21 CFR 807.92;
| 1. | Submitter: | Vatech acucera, Inc.
Address: 2544, Nambuk-daero, Idong-eup, Cheoin-gu, Yongin-si,
Gyeonggi-do, Korea (17138)
Phone No. +82-31-8005-1851
Fax No. +82-31-8005-1888 |
|----|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | 1) Kwon, Kyung Wook
Phone: +82-31-8005-1851
E-mail: kyungwook.kwon@vatechmcis.com
2) Hwang, Haesun
Phone: +82-10-3824-6922
E-mail: Sunny.hwang@medi-guide.com |
| | Date Prepared: | Nov. 3. 2020 |
| 2. | Device Identification | |
| | Device Trade Name | Perfit ZR HT Dental Zirconia blank |
| | Common Name | Milling Block or Dental CAD/CAM Block |
| Device Trade Name | Perfit ZR HT Dental Zirconia blank |
|---|---|
| Common Name | Milling Block or Dental CAD/CAM Block |
| Classification Name, Number | Porcelain Powder for Clinical Use(21 CFR 872.6660) |
| Device Classification | II |
| Product Code | EIH |
3. Predicated or legally marketed devices which are substantially equivalent
- K141724, "Upcera Dental Zirconia Blank and Dental Zirconia Pre-Shaded Blank", manufactured by "Liaoning Upcera"
4. Device Description and Statement of Intended Use
The Perfit ZR HT Dental Zirconia blank consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre-sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit ZR HT Dental Zirconia blank are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
4
They are They are available in different models that differ in various specification and color. There are white zirconia products(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products and multi-layer(A1 SM, A2 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products.
The white zirconia is composed of Zr02+HfO2+Y2O3 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 +Pr203 +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 color 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.
ഗ് Statement of Intended Use
The Perfit ZR HT Dental Zirconia blank / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
-
- Non-clinical Test Conclusion
The results of comparative study performed according to ISO 6872:2015 were indicated The performance of formed zirconia dental blanks meets the applicable requirements of the following FDA recognized standards:
- Non-clinical Test Conclusion
-
. ISO 6872: 2015- Dentistry-Ceramic Materials
-
ISO 13356: 2015, Implant for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
-
. ISO 10993-1:2018, Biological evaluation of medical devices — Part 5: Evaluation and testing within a risk management process
-
. 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('Oral mucosa irritation) and skin sensitization.
-
. ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity
Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015 and ISO 13356: 2015.
According to ISO 6872:2015, the subject device is classified into the following:
Type II: All other forms of ceramic products.
Class 5: Monolithic ceramic for prostheses involving partially or fully covered substructure for four or more units or fully covered substructure for prostheses involving four or mor units.
5
Bench test results allowed to conclude that Perfit ZR HT Dental Zirconia blank is substantially equivalent to the predicate devices for its intended use.
-
- Clinical Test Conclusion Clinical testing was not required for this submission.
-
- Technical Characteristics and Substantial Equivalence The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| No. | Item | Subject Device | Predicate Device |
|---|---|---|---|
| 1 | Device Name | Perfit ZR HT Dental Zirconia blank | Upcera Dental Zirconia Blank and |
| Dental Zirconia Pre-Shaded Blank | |||
| 2 | Manufacturer | Vatech acucera, Inc. | Liaoning Upcera |
| 3 | 510(k) Number | - | K141724 |
| 4 | Product Code | EIH | EIH |
| 5 | Class | II | II |
| 7 | Review Panel | Dental | Dental |
| 8 | Indications | ||
| for | |||
| Use | The Perfit ZR HT Dental Zirconia | ||
| blank are used for dental | |||
| restorations using different CAD / | |||
| CAM or manual milling machines. All | |||
| blanks are processed through dental | |||
| laboratories or by dental | |||
| professionals. | Upcera Dental Zirconia Blank and | ||
| Dental Zirconia Pre-Shaded Blank | |||
| are used for dental restorations | |||
| using different CAD / CAM or manual | |||
| milling machines. All blanks are | |||
| processed through dental | |||
| laboratories or by dental | |||
| professionals. | |||
| 9 | Form | Block, disc form | Block, dis and rod form |
| 10 | Dimensions | Various | Various |
| 11 | Material | Regular: | |
| Zirconia (ZrO2 + Y2O3 + HfO2 + | |||
| Al2O3 ≥ 99.0%) | |||
| Pre-Shaded: | |||
| Zirconia (ZrO2 + Y2O3 + HfO2 + | |||
| Al2O3 ≥98.0%) | |||
| Inorganic pigments (Fe2O3, Pr2O3, | |||
| and Er2O3 1500 °C | Sintering at temperature > 1500 °C | ||
| 14 | Conditions | ||
| of | |||
| Use | Professional use for the fabrication | ||
| of artificial teeth in fixed or | |||
| removable dentures, of jacket | |||
| crowns, facings, and veneers. | Professional use for the fabrication | ||
| of artificial teeth in fixed or | |||
| removable dentures, of jacket | |||
| crowns, facings, and veneers. | |||
| 15 | Single Use | Yes | Yes |
| 16 | Supplied Sterile | No | No |
| 17 | Packaging | Single blank(disk) per box | Single blank(disk) per box |
| 18 | Biocompatibility | Tested to ISO 10993-1 | Tested to ISO 10993-1 |
| Testing | |||
| 19 | Performance | ||
| Testing | Tested to ISO 6872 | Tested to ISO 6872 |
Table 1. General Device Characteristics Comparison Table
6
Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices. We have some minor differences are compared with the predicate device. One is that the predicate device includes rod form more than ours. Shape excluding rod form can be considered the same as our product. Another one is that our device including not only single layer color product but also including multilayer color product to satisfy the aesthetic needs. The different colors are originated from the different constituent of color additive (such as Fe203, Er203, and the different aesthetic effects are originated from the different padding method used in the process of dry pressing, they are very small amount(