The Perfit ZR HT 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.

Device Description

The Perfit ZR HT Dental Zirconia blank consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre-sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.

The Perfit ZR HT Dental Zirconia blank are disc shaped zirconia oxide blanks 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 ZrO2 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(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products and multi-layer(A1 SM, A2 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products.

The white zirconia is composed of Zr02+HfO2+Y2O3 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 +Pr203 +Er2O3. 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 Blocks 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

This document is a 510(k) Premarket Notification from the FDA for a dental product, "Perfit ZR HT Dental Zirconia blank." The document primarily focuses on establishing substantial equivalence to a predicate device based on non-clinical performance data and does not describe a study involving device performance for diagnostic accuracy or human-in-the-loop AI assistance.

Therefore, many of the requested details, such as acceptance criteria for diagnostic performance, sample sizes for test/training sets with data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set ground truth establishment, are not applicable to the information provided in this document.

The document describes material and performance requirements for the dental zirconia blank itself, rather than a diagnostic device that performs a "study" in the typical sense of evaluating an algorithm's accuracy.

Here's a breakdown of what can be extracted from the provided text, and where information is not applicable:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria here are based on meeting established international standards for dental ceramic materials and biocompatibility. The reported device performance is that it met these standards.

Acceptance Criteria (Standard)	Reported Device Performance (Conclusion)
ISO 6872:2015 - Dentistry: Ceramic Materials (Classification: Type II, Class 5)	"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, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)	"The composition of the Dental Zirconia Blocks including the white zirconia and the color zirconia conforms to ISO 13356:2015... and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials."
ISO 10993-1:2018, Biological evaluation of medical devices — Part 5: Evaluation and testing within a risk management process	"Tested to ISO 10993-1" (Implied compliance through testing)
ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.	Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard.
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.	Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard.
ISO 10993-6 Biological evaluation of the medical devices – Part 6: Tests for Local Effects after Implantation.	Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation ('Oral mucosa irritation) and skin sensitization.	Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard.
ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity	Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it pertains to non-clinical bench testing of material properties, not clinical diagnostic performance. The document only mentions "Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015 and ISO 13356: 2015." The tests would involve specific numbers of material samples, but these are not disclosed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the evaluation is based on meeting material and biocompatibility standards through bench testing, not on human interpretation or diagnostic accuracy where expert ground truth would be established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This document is for a dental material (zirconia blank), not an AI-assisted diagnostic device.

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

This information is not applicable. This is a dental material, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is adherence to established international standards for material properties and biocompatibility as determined by standardized laboratory tests. For example, "The composition of the Dental Zirconia Blocks... conforms to ISO 13356:2015" and "Physical and mechanical properties... were evaluated according to ISO 6872:2015."

8. The sample size for the training set

This information is not applicable. This is a dental material subject to non-clinical bench testing, not an AI model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 8, 2021

Vatech acucera, Inc. Kyung Kwon Manager 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si, Gyeonggi-do SOUTH KOREA

Re: K203351

Trade/Device Name: Perfit ZR HT Dental Zirconia blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 12, 2021 Received: January 12, 2021

Dear Kyung 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

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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 (OS) 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 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	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2020
Indications for Use	See PRA Statement below.
510(k) Number (if known)

Device Name

Device Name
Perfit ZR HT Dental Zirconia blank

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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K203351

510(k) Summary

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. +82-31-8005-1851Fax 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:	Nov. 3. 2020
2.	Device Identification
	Device Trade Name	Perfit ZR HT Dental Zirconia blank
	Common Name	Milling Block or Dental CAD/CAM Block

Device Trade Name	Perfit ZR HT Dental Zirconia blank
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

3. Predicated or legally marketed devices which are substantially equivalent

K141724, "Upcera Dental Zirconia Blank and Dental Zirconia Pre-Shaded Blank", manufactured by "Liaoning Upcera"

4. Device Description and Statement of Intended Use

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They are They are available in different models that differ in various specification and color. There are white zirconia products(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products and multi-layer(A1 SM, A2 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products.

ഗ് Statement of Intended Use

The Perfit ZR HT Dental Zirconia blank / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

1. 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 systemic 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 5: 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.

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Bench test results allowed to conclude that Perfit ZR HT Dental Zirconia blank is substantially equivalent to the predicate devices for its intended use.

1. Clinical Test Conclusion Clinical testing was not required for this submission.
1. 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 ZR HT Dental Zirconia blank	Upcera Dental Zirconia Blank andDental Zirconia Pre-Shaded Blank
2	Manufacturer	Vatech acucera, Inc.	Liaoning Upcera
3	510(k) Number	-	K141724
4	Product Code	EIH	EIH
5	Class	II	II
7	Review Panel	Dental	Dental
8	IndicationsforUse	The Perfit ZR HT Dental Zirconiablank are used for dentalrestorations using different CAD /CAM or manual milling machines. Allblanks are processed through dentallaboratories or by dentalprofessionals.	Upcera Dental Zirconia Blank andDental Zirconia Pre-Shaded Blankare used for dental restorationsusing different CAD / CAM or manualmilling machines. All blanks areprocessed through dentallaboratories or by dentalprofessionals.
9	Form	Block, disc form	Block, dis and rod form
10	Dimensions	Various	Various
11	Material	Regular:Zirconia (ZrO2 + Y2O3 + HfO2 +Al2O3 ≥ 99.0%)Pre-Shaded:Zirconia (ZrO2 + Y2O3 + HfO2 +Al2O3 ≥98.0%)Inorganic pigments (Fe2O3, Pr2O3,and Er2O3 < 2.0%)	Regular:Zirconia (ZrO2 + Y2O3 + HfO2 +Al2O3 ≥ 99.0%)Pre-Shaded:Zirconia (ZrO2 + Y2O3 + HfO2 +Al2O3 ≥98.0%)Inorganic pigments (Fe2O3, Pr2O3,and Er2O3 < 2.0%)
12	Color	None, and Pre-shaded (for pre-shaded series) and two differentaesthetic effects (single andmultilayer)	None, and Pre-shaded (for pre-shaded series).
13	Processing	Sintering at temperature > 1500 °C	Sintering at temperature > 1500 °C
14	ConditionsofUse	Professional use for the fabricationof artificial teeth in fixed orremovable dentures, of jacketcrowns, facings, and veneers.	Professional use for the fabricationof artificial teeth in fixed orremovable dentures, of jacketcrowns, facings, and veneers.
15	Single Use	Yes	Yes
16	Supplied Sterile	No	No
17	Packaging	Single blank(disk) per box	Single blank(disk) per box
18	Biocompatibility	Tested to ISO 10993-1	Tested to ISO 10993-1
	Testing
19	PerformanceTesting	Tested to ISO 6872	Tested to ISO 6872

Table 1. General Device Characteristics Comparison Table

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Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices. We have some minor differences are compared with the predicate device. One is that the predicate device includes rod form more than ours. Shape excluding rod form can be considered the same as our product. Another one is that our device including not only single layer color product but also including multilayer color product to satisfy the aesthetic needs. The different colors are originated from the different constituent of color additive (such as Fe203, Er203, and the different aesthetic effects are originated from the different padding method used in the process of dry pressing, they are very small amount(< 2.0%).These differences do not raise any concerns in the subject device, and this is demonstrated by biocompatibility testing.

7.	Conclusion	The information discussed above demonstrates that Perfit ZR HTDental Zirconia blank, as effective, and performs as well as orbetter than the predicate devices
8.	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

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.