(30 days)
Not Found
No
The 510(k) summary describes a material (zirconia block) used in the manufacturing of dental restorations. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The device is a physical material processed by CAD/CAM machines and dental technicians.
No.
The device is a raw material (zirconia block) used by dental professionals to create dental restorations, such as crowns and bridges, which are themselves therapeutic devices. The block itself does not directly exert a therapeutic effect on a patient.
No
Explanation: The device is a material (zirconia block) used for manufacturing dental restorations like crowns and bridges. It does not perform any diagnostic function; its purpose is to be milled and sintered into a physical prosthesis.
No
The device is a physical block of zirconium oxide used for creating dental restorations, not a software program.
Based on the provided information, the Perfit FS Dental Zirconia Fully Sintered Block is not an In Vitro Diagnostic (IVD) device.
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 placed in vivo (in the patient's mouth).
- Device Description: The description details the material composition and how it is processed to create dental prosthetics. It does not describe a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device is a material used to fabricate a physical restoration.
Therefore, the Perfit FS Dental Zirconia Fully Sintered Block 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 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, and further firing. It is normally pre shaded, fully sintered 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. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the Zr02 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(White) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, White) color products , Shade multi-layer(ML A1/A2/A3, A1M, A2M, A3M, A3.5M, A4M, B1M, B2M, B3M, B4M, C1M, C2M, C3M, C4M, D2M, D3M, D4M) 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 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 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 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 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 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 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.)
Flexural strength: ≥500 MPa
Solubility:
§ 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
October 6, 2022
Vatech Acucera, Inc. Kwon Wook Manager 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si, Gyeonggi-do 17138 SOUTH KOREA
Re: K222686
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: August 22, 2022 Received: September 6, 2022
Dear Kwon Wook:
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 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 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
Indications for Use
510(k) Number (if known) K222686
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-K222686
The following 510(k) summary is being submitted as required by 21 CFR 807.92;
| 5.1 Submitter: | Vatech acucera, Inc.
Address: 2544, Nambuk-daero, Idong-eup, Cheoin-gu, Yongin-si
Gyeonggi-do, Korea (17138)
Phone No. +82-31-8005-1855
Fax No. +82-31-8005-1888 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | 1) Kim, Gyeong Rok
Phone: +82-31-8005-1855
E-mail: gyeongrok.kim@vatechmcis.com
- Kwon, Kyung Wook
Phone: +82-31-8005-1851
E-mail: kyungwook.kwon@vatechmcis.com |
Date Prepared: August 22, 2022
5.2 Device Identification
| 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 |
| 872.6660) | |
| Device Classification | II |
| Product Code | EIH |
5.3 Predicated or legally marketed devices which are substantially equivalent
- . Predicated device: K203590, "Perfit FS Dental Zirconia Blank, Perfit ZR UT Dental Zirconia Blank", manufactured by "Vatech acucera, Inc."
5.4 Device Description and Statement of Intended Use
The Perfit FS Dental Zirconia Fully Sintered Block consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre shaded, fully sintered 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. At the completion of the machining steps, the
4
dental restoration is fired (i.e., sintered) in the oven to harden the Zr02 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(White) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, White) color products , Shade multi-layer(ML A1/A2/A3, A1M, A2M, A3M, A3.5M, A4M, B1M, B2M, B3M, B4M, C1M, C2M, C3M, C4M, D2M, D3M, D4M) 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 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 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.
5.5 Statement of Intended 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.
5.6 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 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: Monolithic ceramic for prostheses involving partially or fully covered substructure
5
for four or more units or fully covered substructure for prostheses involving four or mor units.
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.
5.7 Clinical Test Conclusion
Clinical testing was not required for this submission.
5.8 Technical Characteristics and Substantial Equivalence
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| No. | Item | Subject Device | Predicate Device |
|---|---|---|---|
| 1 | Device Name | Perfit FS Dental Zirconia Fully Sintered Block | Perfit FS Dental Zirconia Fully Sintered Block |
| 2 | Manufacturer | Vatech acucera, Inc. | Vatech acucera, Inc. |
| 3 | 510(k) Number | K222686 | K203590 |
| 4 | Product Code | EIH | EIH |
| 5 | Class | II | II |
| 7 | Review Panel | Dental | Dental |
| 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. | 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. |
| 9 | Form | Block form | Block form |
| 10 | Dimension | Various | Various |
| 11 | Applied for(Milling Machine) | CEREC inLab(Sirona) | CEREC inLab(Sirona) |
| 12 | Material | Regular: | |
| Zirconia (ZrO2 + Y2O3 +Nb2O5 | |||
| Al2O3 ≥ 99.0%) | |||
| Pre-Shaded: Zirconia (ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥99.0%) | |||
| Inorganic pigments (Fe2O3, MnO2, and Er2O3 |