(129 days)
Not Found
No
The device description focuses on the material composition and physical properties of dental zirconia blanks used in traditional CAD/CAM milling processes. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a material (zirconium oxide blank) used to manufacture dental restorations like crowns and bridges, not a device that directly provides therapy or treatment to a patient.
No
The device is a material (zirconium oxide blank) used for manufacturing dental restorations, not for diagnosing a condition or disease.
No
The device is a physical dental blank made of zirconium oxide, intended for milling into dental restorations. It is a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations (crowns, bridges, veneers, etc.) using CAD/CAM or manual milling machines. This is a manufacturing process for a medical device that will be implanted or placed in the body.
- Device Description: The description details the material composition and how the blanks are processed to form artificial teeth. This is about the physical creation of a prosthetic device.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or calibrators for testing.
The device is a material used in the creation of a dental prosthetic, which is a medical device, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Perfit ZR ST Dental Zirconia blank and Perfit ZR UT 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 (comma separated list FDA assigned to the subject device)
EIH
Device Description
The Perfit ZR ST Dental Zirconia blank and Perfit ZR UT 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 ST Dental Zirconia blank and Perfit ZR UT 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 , Shade multi-layer(A1 SM, A2 SM, A3 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 and Trans&Shade multi-layer(A1 TM, A2 TM, A3 TM, A3 TM, A4 TM, B1 TM, B2 TM, B3 TM, B4 TM, C1 TM, C2 TM, C3 TM, C4 TM, D2 TM, D3 TM, D4 TM) color products.
The white zirconia is composed of ZrO2+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 +Er203. 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
Patient's teeth
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 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 4: 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 testing was performed per ISO 6872:2015 and ISO 13356:2015 to ensure that the "Perfit ZR ST Dental Zirconia blank" and "Perfit ZR UT Dental Zirconia blank" met it specifications. All tests were verified to meet acceptance criteria.
Biocompatibility test results:
Cytotoxicity: No cytotoxic reactivity under the condition of the study
Sensitization: Not a sensitizer under the conditions of the study
Intracutaneous reactivity: No intracutaneous reactivity
Systemic toxicity(acute): No systemic toxicity under the condition of the study
Genotoxicity: No possibility of genotoxicity under the condition of the study
A series of tests were conducted on the subject device for the Biocompatibility
Bench test results allowed to conclude that Perfit ZR ST & Perfit ZR UT 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 (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). On the left is the Department of Health & Human Services USA 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.
April 5, 2021
Vatech Acucera, Inc. Kyung Wook Kwon Manager 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si. Gyeonggi-do 17138 Korea, South
Re: K203499
Trade/Device Name: Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 30, 2020 Received: January 7, 2021
Dear Kyung Wook 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 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.
Bobak Shirmohammadi -S
For Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
Indications for Use (Describe)
Perfit ZR ST Dental Zirconia blank and Perfit ZR UT 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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3
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: | Mar. 31. 2021 |
| | 510(k) number: | K203499 |
| 2. | Device Identification | Perfit ZR ST Dental Zirconia blank |
| Device Trade Name | Perfit ZR ST Dental Zirconia blank
Perfit ZR UT 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 |
Predicated or legally marketed devices which are substantially equivalent 3.
- 9 Primary predicate: K141724, "Upcera Dental Zirconia Blank and Dental Zirconia Pre-Shaded Blank", manufactured by "Liaoning Upcera"
Device Description and Statement of Intended Use 4.
The Perfit ZR ST Dental Zirconia blank and Perfit ZR UT 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 ST Dental Zirconia blank and Perfit ZR UT 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 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 , Shade multi-layer(A1 SM, A2 SM, A3 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 and Trans&Shade multi-layer(A1 TM, A2 TM, A3 TM, A3 TM, A4 TM, B1 TM, B2 TM, B3 TM, B4 TM, C1 TM, C2 TM, C3 TM, C4 TM, D2 TM, D3 TM, D4 TM) color products.
The white zirconia is composed of ZrO2+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 +Er203. 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.
- ഹ Statement of Intended Use
Perfit ZR ST Dental Zirconia blank and Perfit ZR UT 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.
6. 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 4: 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
5
units.
Bench testing was performed per ISO 6872:2015 and ISO 13356:2015 to ensure that the "Perfit ZR ST Dental Zirconia blank" and "Perfit ZR UT Dental Zirconia blank" met it specifications. All tests were verified to meet acceptance criteria.
| Biological
| endpoint | Reference | Test result and SE |
|---|---|---|
| Cytotoxicity | ISO 10993-05 | No cytotoxic reactivity under the condition of the |
| study | ||
| Sensitization | ISO 10993-10 | Not a sensitizer under the conditions of the study |
| Intracutaneous | ||
| reactivity | ISO 10993-10 | No intracutaneous reactivity |
| Systemic | ||
| toxicity(acute) | ISO 10993-11 | No systemic toxicity under the condition of the |
| study | ||
| Genotoxicity | ISO 10993-03 | No possibility of genotoxicity under the condition of |
| the study |
A series of tests were conducted on the subject device for the Biocompatibility
Bench test results allowed to conclude that Perfit ZR ST & Perfit ZR UT 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.
- Clinical Test Conclusion
-
Technical Characteristics and Substantial Equivalence 8. 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 ST & Perfit ZR UT Dental Zirconia blank | Upcera Dental Zirconia Blank and Dental Zirconia Pre-Shaded Blank |
| 2 | Manufacturer | Vatech acucera, Inc. | Liaoning Upcera |
| 3 | 510(k) Number | K203499 | K141724 |
| 4 | Product Code | EIH | EIH |
| 5 | Class | II | II |
| 7 | Review Panel | Dental | Dental |
| 8 | Indications for Use | The Perfit ZR ST & Perfit ZR UT 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 + | Regular: | ||
| Zirconia (ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 99.0%) | |||
| Pre-Shaded: | |||
| Zirconia (ZrO2 + Y2O3 + HfO2 + |
Table 1. General Device Characteristics Comparison Table
6
| | | 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 Testing | Tested to ISO 10993-1 | Tested to ISO 10993-1 |
| 19 | Performance Testing | Tested to ISO 6872 | Tested to ISO 6872 |
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(