(198 days)
No
The device is a physical block of zirconia material used for milling dental restorations. The description focuses on the material composition, physical properties, and intended use with CAD/CAM machines, with no mention of AI or ML.
Yes.
The device, Perfit FS Dental Zirconia Fully Sintered Block, is used for dental restorations like crowns, bridges, and veneers, which are implantable devices designed to replace or support a body part and restore its function.
No
The device is a dental material (zirconia block) used to create restorations like crowns and bridges. It does not gather or interpret data from the body to provide information about a patient's health status, which is the primary function of a diagnostic device.
No
The device description clearly states it is a physical block made of zirconium oxide used for milling dental restorations, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for creating dental restorations (crowns, bridges, veneers, etc.) using CAD/CAM or manual milling. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a block of zirconium oxide used for milling into dental prosthetics. It's a material for fabrication, not a test or assay performed on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
The device is a material used in the creation of a dental prosthetic, which is a medical device, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. 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
The Perfit FS Dental Zirconia Fully Sintered Block consists of zirconium oxide which compresses ceramic for milling, grinding. It is a preshaded, fully sintered product and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit FS Dental Zirconia Fully Sintered Block are zirconia oxide block 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.
They are available in different models that differ in various specification and color. There are white zirconia products(White) and colored zirconia products, and colored zirconia is also divided into Monolaver(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products , Shade multi-laver(ML A1/A2/A3, A1M, A2M, A3.5M, A4M)color products.
The white zirconia is composed of Zr02+Y203+Nb205 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 and other oxide.
The composition of the Dental Zirconia Block 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 (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 testing conducted on the subject formed zirconia dental blanks met 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 svstemic 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: Partially or fully covered substructure for three-unit prostheses involving molar restoration.
Bench test results allowed to conclude that Perfit FS Dental Zirconia Fully Sintered Block 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.
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 24, 2021
Vatech Acucera, Inc. Kyung Wook Kwon Manager 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si, Gyeonggi-do 17138 KOREA
Re: K203590
Trade/Device Name: Perfit FS Dental Zirconia Fully Sintered Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 26, 2021 Received: May 26, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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.
For Michael E. Adjodha, M.ChE. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203590
Device Name
Perfit FS Dental Zirconia Fully Sintered Block
Indications for Use (Describe)
The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks 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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510(k) Summary K203590
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: | June 23. 2021 |
2. Device Identification
| 510(k) Submission | K203590 |
|---|---|
| Device Trade Name | Perfit FS Dental Zirconia Fully Sintered Block |
| 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.
- Predicated device: K141724, "Upcera Dental Zirconia Blank and Dental Zirconia Pre-● Shaded Blank", manufactured by "Liaoning Upcera"
- . Reference device: K203499, "Perfit ZR ST Dental Zirconia Blank, Perfit ZR UT Dental Zirconia Blank", manufactured by "Vatech acucera, Inc.".
4. Device Description
The Perfit FS Dental Zirconia Fully Sintered Block consists of zirconium oxide which compresses ceramic for milling, grinding. It is a preshaded, fully sintered product and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit FS Dental Zirconia Fully Sintered Block are zirconia oxide block made available in different versions and chemical compositions of various colors, shades and dimensions
4
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.
They are available in different models that differ in various specification and color. There are white zirconia products(White) and colored zirconia products, and colored zirconia is also divided into Monolaver(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products , Shade multi-laver(ML A1/A2/A3, A1M, A2M, A3.5M, A4M)color products.
The white zirconia is composed of Zr02+Y203+Nb205 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 and other oxide.
The composition of the Dental Zirconia Block 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.
5. Statement of Indications for Use
The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Non-clinical Test Conclusion 6.
The results of comparative study performed according to ISO 6872:2015 were indicated The testing conducted on the subject formed zirconia dental blanks met 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 svstemic 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: Partially or fully covered substructure for three-unit prostheses involving molar
5
restoration.
Bench test results allowed to conclude that Perfit FS Dental Zirconia Fully Sintered Block is substantially equivalent to the predicate devices for its intended use.
7. Clinical Test Conclusion
Clinical testing was not required for this submission.
8. Technical Characteristics and Substantial Equivalence
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
Table 1. General Device Characteristics Comparison Table
| No. | Item | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|---|
| 1 | Device Name | Perfit FS Dental | |||
| Zirconia Fully | |||||
| Sintered Block | Upcera Dental | ||||
| Zirconia Blank | |||||
| and Dental | |||||
| Zirconia Pre- | |||||
| Shaded Blank | Perfit ZR ST Dental | ||||
| Zirconia Blank, | |||||
| Perfit ZR UT Dental | |||||
| Zirconia Blank | |||||
| 2 | Manufacturer | Vatech acucera, | |||
| Inc. | Liaoning Upcera | Vatech acucera, Inc. | |||
| 3 | 510(k) Number | K203590 | K141724 | K203499 | |
| 4 | Product Code | EIH | EIH | EIH | Identical |
| 5 | Class | II | II | II | Identical |
| 7 | Review Panel | Dental | Dental | Dental | Identical |
| 8 | Indications for | ||||
| Use | The Perfit FS | ||||
| Dental Zirconia | |||||
| Fully Sintered | |||||
| Block is used for | |||||
| dental | |||||
| restorations | |||||
| using different | |||||
| CAD / CAM or | |||||
| manual milling | |||||
| machines. All | |||||
| blocks 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. | 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. | Identical | ||||
| 9 | Form | Block form | Block, disc, and | ||
| rod form | Block, disc form | Identical | |||
| 10 | Dimension | Various | Various | Various | Identical |
| 11 | Material | Regular: | |||
| Zirconia (ZrO2 + | |||||
| Y2O3 +Nb2O5 | |||||
| Al2O3 > | Regular: | ||||
| Zirconia (ZrO2 + | |||||
| Y2O3 + HfO2 + | |||||
| Al2O3 > | Zirconia (ZrO2 + | ||||
| Y2O3 + HfO2 |
- Al2O3 ≥ 99.0%)
Pre-Shaded: | Different 1 |
| | | | | | |
| | | 99.0%)
Pre-Shaded:
Zirconia (ZrO2 +
Y203 + Nb2O5 +
Al2O3 ≥99.0%)
Inorganic
pigments
(Fe2O3, MnO2,
and Er2O3