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 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.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary regarding the Perfit FS Dental Zirconia Fully Sintered Block, focusing on acceptance criteria and the study proving it meets those criteria:

Device: Perfit FS Dental Zirconia Fully Sintered Block
K Number: K222686
Predicate Device: K203590, "Perfit FS Dental Zirconia Blank, Perfit ZR UT Dental Zirconia Blank" manufactured by Vatech acucera, Inc.

This submission is for a dental material (zirconia blocks) used for creating dental restorations, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study designs relevant to AI (like MRMC studies, human-in-the-loop performance, expert consensus for ground truth, training set information) are not applicable to this type of medical device.

The acceptance criteria here pertain to the physical, chemical, and biological properties of the material to ensure it is safe and performs as intended.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ISO Standards / Predicate Device)	Reported Device Performance (Subject Device)
Material Composition Conformity
ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥ 99.0% (Regular White zirconia)	Composed of ZrO2+Y2O3+Nb2O5 and additional inorganic pigment: Al2O3 and Other oxide (white zirconia)
ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥ 99.0% (Pre-Shaded zirconia)	Derived from same zirconia powder as regular white zirconia with addition of Fe2O3 and other oxide (colored zirconia)
Conformity to ISO 13356:2015 (Material)	Conforms to ISO 13356:2015
Inorganic pigments (Fe2O3, MnO2, and Er2O3 < 1.0%)	Inorganic pigments specified (Fe2O3 and other oxide for colored zirconia) < 1.0% (as per predicate)
Mechanical/Physical Properties Conformity
Conformity to ISO 6872:2015/Amd1:2018 (Performance)	Conforms to ISO 6872:2015/Amd1:2018
Flexural strength ≥ 500 MPa	≥ 500 MPa
Solubility < 2000 µg/cm²	< 2000 µg/cm²
Radioactive: uranium-238 active concentration ≤ 1.0 Bq/g	uranium-238 active concentration ≤ 1.0 Bq/g
Biocompatibility Conformity
Tested to ISO 10993-1:2018 (Biological evaluation)	Tested to ISO 10993-1:2018
Tested to ISO 10993-3:2014 (Genotoxicity, carcinogenicity, reproductive toxicity)	Tested to ISO 10993-3:2014
Tested to ISO 10993-5:2009 (In Vitro cytotoxicity)	Tested to ISO 10993-5:2009
Tested to ISO 10993-6 (Local Effects after Implantation)	Tested to ISO 10993-6
Tested to ISO 10993-10:2010 (Irritation and skin sensitization)	Tested to ISO 10993-10:2010
Tested to ISO 10993-11:2017 (Systemic toxicity)	Tested to ISO 10993-11:2017
Functional Equivalence
Identical Indications for Use	Identical (for dental restorations using CAD/CAM or manual milling machines)
Block form	Block form
Various dimensions	Various
Applied for (Milling Machine): CEREC inLab (Sirona)	CEREC inLab (Sirona)
Conditions of Use: Professional use for fabrication of artificial teeth in fixed or removable dentures, crowns, facings, and veneers	Identical
Single Use: Yes	Yes
Supplied Sterile: No	No

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "test set" in the traditional sense of a clinical or image-based study. Instead, it refers to bench testing of the material itself according to various ISO standards. These standards typically specify the number of samples required for each particular test (e.g., flexural strength, solubility, biocompatibility assays). The provenance of the data is the manufacturer, Vatech acucera, Inc., as they performed the comparative study and conducted the bench tests. It is retrospective in the sense that the results are presented after the tests were completed. There is no information regarding the country of origin of "data" in the context of patient data, as this is a material science evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable for this type of device. The "ground truth" for material properties is established by adherence to recognized international standards (ISO standards) and by direct measurement of physical, chemical, and biological characteristics, not through expert human interpretation of images or clinical outcomes in the same way an AI diagnostic device would be evaluated. The "experts" involved would be material scientists, chemists, and toxicologists who conducted and interpreted these standardized tests.

4. Adjudication Method for the Test Set

This question is not applicable for this type of device. Adjudication methods like "2+1" or "3+1" are used to establish consensus or resolve discrepancies among human readers or experts when determining ground truth for clinical or image-based assessments. For material testing, the "ground truth" is derived directly from standardized measurement procedures and acceptance limits defined by the ISO standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools (often AI-assisted) and how they impact human reader performance. The Perfit FS Dental Zirconia Fully Sintered Block is a dental restoration material, not a diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

International Standards: Adherence to the specifications and performance criteria defined in recognized ISO standards (e.g., ISO 6872:2015, ISO 13356:2015, ISO 10993 series for biocompatibility).
Direct Measurement & Material Analysis: Physical, chemical, and biological properties (e.g., flexural strength, solubility, elemental composition, cytotoxicity) are directly measured and compared against the defined limits within these standards and against the predicate device.
Predicate Device Equivalence: The subject device's properties (material, performance, indications for use) are directly compared to those of the legally marketed predicate device (K203590) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a material, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a material, this question does not apply.

Summary

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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 (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

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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)

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-siGyeonggi-do, Korea (17138)Phone No. +82-31-8005-1855Fax No. +82-31-8005-1888
Contact Person:	1) Kim, Gyeong RokPhone: +82-31-8005-1855E-mail: gyeongrok.kim@vatechmcis.com2) Kwon, Kyung WookPhone: +82-31-8005-1851E-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(21872.6660)
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

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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.

5.5 Statement of Intended Use

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:Zirconia (ZrO2 + Y2O3 +Nb2O5Al2O3 ≥ 99.0%)Pre-Shaded: Zirconia (ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥99.0%)Inorganic pigments (Fe2O3, MnO2, and Er2O3 < 1.0%)	Regular:Zirconia (ZrO2 + Y2O3 +Nb2O5Al2O3 ≥ 99.0%)Pre-Shaded: Zirconia (ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥99.0%)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	BiocompatibilityTesting	Tested to ISO 10993-1	Tested to ISO 10993-1
22	PerformanceTesting	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 DentalZirconia Fully Sintered Block, as effective, and performs as well asor better than the predicate devices
5.10	Declarations	This summary includes only information that is also covered in thebody of the 510(k).This summary does not contain any puffery or unsubstantiatedlabeling claims.Considering the existent models' design aspects such as theirtechnical characteristics, it is warranted that the model to be addeddoes not have any change that can have an impact on clinicalperformance and safety.

Regulation Number and Section

§ 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.