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. 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.

AI/ML Overview

The document provided is a 510(k) premarket notification for a dental zirconia block. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain information about software or an AI-powered device, nor does it detail a study proving device performance against acceptance criteria in the way envisioned by the prompt's request for AI/diagnostic performance metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details for an AI-powered device. The document is about a material used in dentistry, not an AI software or diagnostic device that would involve ground truth, expert readers, or AUC.

Here's an explanation of why the requested information cannot be extracted from this document:

Device Type: The device is "Perfit FS Dental Zirconia Fully Sintered Block," which is a material used for dental restorations. It is not an AI/ML-powered diagnostic tool.
Performance Metrics: The performance criteria mentioned ("Flexural strength," "Solubility," "Radioactive uranium-238 active concentration") are physical and chemical properties of the material, not diagnostic or AI performance metrics like sensitivity, specificity, or AUC.
Study Type: The studies conducted are "Non-clinical Test Conclusion" based on ISO standards (e.g., ISO 6872:2015 for ceramic materials, ISO 10993 for biocompatibility) to assess the material's properties and safety. These are not clinical studies for diagnostic accuracy or human-in-the-loop performance.
Ground Truth/Experts/Adjudication: These concepts are relevant for diagnostic devices where a truth reference (e.g., pathology, clinical outcome) is established by experts to evaluate the device's accuracy. They are not applicable to the evaluation of a dental material's physical properties.
Training/Test Set: These relate to a machine learning model's development and evaluation, which is not described in this document.

In summary, the provided document is a regulatory submission for a dental material, not an AI/ML-powered diagnostic device. Therefore, the specific questions about acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, and adjudication methods are not addressed in this text.

Summary

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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

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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

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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)

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-siGyeonggi-do, Korea (17138)Phone No. +82-31-8005-1851Fax No. +82-31-8005-1888
Contact Person:	1) Kwon, Kyung WookPhone: +82-31-8005-1851E-mail: kyungwook.kwon@vatechmcis.com2) Hwang, HaesunPhone: +82-10-3824-6922E-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 are zirconia oxide block made available in different versions and chemical compositions of various colors, shades and dimensions

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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

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

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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 DentalZirconia FullySintered Block	Upcera DentalZirconia Blankand DentalZirconia Pre-Shaded Blank	Perfit ZR ST DentalZirconia Blank,Perfit ZR UT DentalZirconia 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 forUse	The Perfit FSDental ZirconiaFully SinteredBlock is used fordentalrestorationsusing differentCAD / CAM ormanual millingmachines. Allblocks areprocessedthrough dentallaboratories orby dentalprofessionals.	Upcera DentalZirconia Blankand DentalZirconia Pre-Shaded Blankare used fordentalrestorationsusing differentCAD / CAM ormanual millingmachines. Allblanks areprocessedthrough dentallaboratories orby dentalprofessionals.	Perfit ZR ST DentalZirconia blank andPerfit ZR UT DentalZirconia blank areused for dentalrestorations usingdifferent CAD/CAMor manual millingmachines. Allblanks areprocessed throughdental laboratoriesor by dentalprofessionals.	Identical
9	Form	Block form	Block, disc, androd form	Block, disc form	Identical
10	Dimension	Various	Various	Various	Identical
11	Material	Regular:Zirconia (ZrO2 +Y2O3 +Nb2O5Al2O3 >	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%)Inorganicpigments(Fe2O3, MnO2,and Er2O3 <1.0%)	99.0%)Pre-Shaded:Zirconia (ZrO2 +Y2O3 + HfO2 +Al2O3 ≥98.0%)Inorganicpigments(Fe2O3, Pr2O3,and Er2O3 <2.0%)	Zirconia (ZrO2 +Y2O3 + HfO2+ Al2O3 ≥98.0%)Inorganic pigments(Fe2O3, Pr2O3, andEr2O3 < 2.0%)
12	Color	None, and Pre-shaded (forpreshadedseries)	None, and Pre-shaded (forpreshadedseries).	None, and Pre-shaded (forpreshaded series).	Identical
13	Flexuralstrength	≥500 MPa	- - -	≥ 500 MPa	Identical
14	Solubility	<2000µg/cm²	- - -	<2000µg/cm²	Identical
15	Radioactive	uranium-238activeconcentration ≤1.0 Bq/g.	- - -	uranium-238 activeconcentration ≤ 1.0Bq/g.	Identical
16	ConditionsofUse	Professional useforthefabricationofartificial teeth infixedorremovabledentures,ofjacket crowns,facings,andveneers.	Professional useforthefabricationofartificial teeth infixedorremovabledentures,ofjacket crowns,facings,andveneers.	Professional use forthe fabrication ofartificial teethinfixed or removabledentures, of jacketcrowns, facings,and veneers.	Identical
17	Single Use	Yes	Yes	Yes	Identical
18	Supplied Sterile	No	No	No	Identical
19	Packaging	3 ea blocks perbox	Singleblank(disk)perbox	Single blank(disk)per box; 4 ea blocksper box	Different 2
20	BiocompatibilityTesting	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1	Identical
21	PerformanceTesting	Tested to ISO6872	Tested to ISO6872	Tested to ISO 6872,Class 4	Identical

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Submitter: Vatech acucera, Inc.

Our device is equivalent to the predicate device in terms of indications for use, design, material, and processing. There are some minor differences as compared to the predicate device. One is that the predicate device is available in rod, block or disc form vs the subject device is only available in block form. Shape excluding rod form can be considered the same as the subject device. Another difference is the subject device includes not only single layer color product but also multilayer color product. The

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different colors are derived from the different constituents of color additive (such as Fe203, Er203, MnO2), and the different aesthetic effects are derived from the different padding method used in the process of dry pressing. They are present in very small amounts(< 1.0%).

Also, the subject device contains Nb205.

Both the subject and predicate device have similar physical/mechanical and biocompatibility properties that met the requirements of ISO 6872 (Class 4) and ISO 10993.

The information discussed above demonstrates that Perfit FS Dental Zirconia Fully Sintered Block is substantially equivalent to 7. Conclusion the identified predicate device.

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.