Perfit FS Dental Zirconia Fully Sintered Block

K222686 · Vatech Acucera, Inc. · EIH · Oct 6, 2022 · Dental

Device Facts

• Record ID: K222686
• Device Name: Perfit FS Dental Zirconia Fully Sintered Block
• Applicant: Vatech Acucera, Inc.
• Product Code: EIH · Dental
• Decision Date: Oct 6, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Device consists of yttria-stabilized zirconium oxide ceramic blocks; used by dental technicians in laboratories or dental professionals. Input: anatomical rendering of patient teeth via CAD/CAM systems. Operation: milling/grinding of blocks to shape artificial teeth; subsequent sintering in oven to harden ZrO2. Output: final dental restorations (crowns, bridges, veneers, inlays, onlays). Benefits: provides durable, biocompatible, color-matched prosthetic teeth. Device is non-sterile, single-use.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ISO 6872:2015 (dentistry ceramic materials) and ISO 13356:2015 (yttria-stabilized tetragonal zirconia). Biocompatibility confirmed via ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity).

Technological Characteristics

Material: Yttria-stabilized tetragonal zirconia (Y-TZP) with inorganic pigments (Fe2O3, MnO2, Er2O3). Conforms to ISO 13356:2015 and ISO 6872:2015. Flexural strength ≥500 MPa. Solubility <2000µg/cm². Radioactive concentration (U-238) ≤ 1.0 Bq/g. Form: Pre-sintered blocks for CAD/CAM milling.

Indications for Use

Indicated for dental restorations including crowns, bridges, veneers, inlays, and onlays in patients requiring artificial teeth fabrication.

Regulatory Classification

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.

Predicate Devices

• Perfit FS Dental Zirconia Blank, Perfit ZR UT Dental Zirconia Blank (K203590)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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.<br>Address: 2544, Nambuk-daero, Idong-eup, Cheoin-gu, Yongin-si<br>Gyeonggi-do, Korea (17138)<br>Phone No. [phone]<br>Fax No. [phone] |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | 1) Kim, Gyeong Rok<br>Phone: [phone]<br>E-mail: [e-mail]<br><br>2) Kwon, Kyung Wook<br>Phone: [phone]<br>E-mail: [e-mail] |

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<br>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

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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

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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:<br>Zirconia (ZrO2 + Y2O3 +Nb2O5<br>Al2O3 ≥ 99.0%)<br>Pre-Shaded: Zirconia (ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥99.0%)<br>Inorganic pigments (Fe2O3, MnO2, and Er2O3 < 1.0%) | Regular:<br>Zirconia (ZrO2 + Y2O3 +Nb2O5<br>Al2O3 ≥ 99.0%)<br>Pre-Shaded: Zirconia (ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥99.0%)<br>Inorganic pigments (Fe2O3, MnO2, and Er2O3 < 1.0%) |
| 13 | Color | None, and Pre-shaded (for preshaded series) | None, and Pre-shaded (for preshaded series) |
| 14 | Flexural strength | ≥500 MPa | ≥500 MPa |
| 15 | Solubility | <2000µg/cm² | <2000µg/cm² |
| 16 | Radioactive | uranium-238 active concentration ≤ 1.0 Bq/g. | uranium-238 active concentration ≤ 1.0 Bq/g. |
| 17 | Conditions of Use | Professional use for the fabrication of artificial teeth in fixed or removable dentures, of jacket | Professional use for the fabrication of artificial teeth in fixed or removable dentures, of jacket |

## Table 1. General Device Characteristics Comparison Table

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## Submitter: Vatech acucera, Inc.

| | | crowns, facings, and veneers. | crowns, facings, and veneers. |
|----|-----------------------------|-------------------------------|-------------------------------|
| 18 | Single Use | Yes | Yes |
| 19 | Supplied Sterile | No | No |
| 20 | Packaging | 3ea or 5 ea blocks per box | 3 ea blocks per box |
| 21 | Biocompatibility<br>Testing | Tested to ISO 10993-1 | Tested to ISO 10993-1 |
| 22 | Performance<br>Testing | Tested to ISO 6872 | Tested to ISO 6872 |

Compared to the predicated device, the subject device has the same intended use, form and conditions of use, raw materials, and specifications of technology/mechanically. There only have differences in the packaging unit.

Although the subject device and predicate device are different in their packaging unit, their main components are substantially equivalent, and the differences do not affect the substantial equivalence of the subject device when compared to the predicate device.

| 5.9 | Conclusion | The information discussed above demonstrates that Perfit FS Dental<br>Zirconia Fully Sintered Block, as effective, and performs as well as<br>or better than the predicate devices |
|------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.10 | Declarations | This summary includes only information that is also covered in the<br>body of the 510(k).<br>This summary does not contain any puffery or unsubstantiated<br>labeling claims.<br>Considering the existent models' design aspects such as their<br>technical characteristics, it is warranted that the model to be added<br>does not have any change that can have an impact on clinical<br>performance and safety. |