Perfit CL can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

Device Description

This medical device is used to color the zirconia pre- sintered body, and it is a color solution that makes the color similar to natural teeth by using a brush and immersion.

AI/ML Overview

The provided document is a 510(k) summary for a dental coloring liquid named "Perfit CL." Based on the content, here's a breakdown of the requested information:

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

The document does not specify discrete "acceptance criteria" with numerical targets in the same way one might for diagnostic accuracy metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device through various non-clinical tests and technical characteristic comparisons. The reported performance is that the device met these criteria by demonstrating equivalence.

Acceptance Criteria Category	Reported Device Performance (Perfit CL)
Material Safety (Biocompatibility)	- Genotoxicity (Ames test & Micronucleus): Compliant with ISO 10993-3
	- Cytotoxicity: Compliant with ISO 10993-5
	- Sensitization & Irritation: Compliant with ISO 10993-10
	- Acute systemic toxicity (Oral): Compliant with ISO 10993-11
	- Overall Biocompatibility: Tested to ISO 10993-1
Material Performance	- Shelf-Life: Satisfactory
	- Appearance: Satisfactory
	- Volume: Satisfactory
	- Packaging: Satisfactory
	- Dissolution analysis: Satisfactory
	- Color stability: Satisfactory
	- Performance Testing: Tested to ISO 6872
Technical Characteristics	- Technology: Water-based with inorganic pigments (Same as predicate)
	- Indications for Use: Same as predicate
	- Principles of Operation: Same as predicate
	- Prescription Use: Same as predicate
	- Target population: Same as predicate
	- Type of Packaging: Same as predicate
	- pH: Same as predicate (5.5~8.0)
	- Boiling Point: Same as predicate (100°C)
	- Density: Same as predicate (1.00~1.10 g/cm³)
	- Specific Gravity: Same as predicate (1.00~1.10)
	- Solubility in Water: Same as predicate (100%)
	- Sterility: Non-Sterile (Same as predicate)
Substantial Equivalence	Concluded to be substantially equivalent to the predicate device based on all testing and characteristic comparisons.

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

The document primarily describes non-clinical bench testing rather than clinical or user performance studies on a "test set" of patient data. For the listed non-clinical tests (e.g., biocompatibility, shelf-life, physical properties), the sample sizes are not specified. The provenance of the data (country of origin, retrospective/prospective) is also not stated beyond the applicant's origin in South Korea.

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 document describes non-clinical testing of a dental coloring liquid, not a diagnostic or AI-assisted device requiring expert-established ground truth. The "ground truth" for the tests would be established by standard laboratory methods and equipment as per the referenced ISO standards. The document mentions that differences in packaging volume, shade, and storage conditions "can be differentiated depending on experts' determination," implying that dental technicians/experts evaluate the aesthetic outcome in practice, but this is not defined as part of the formal 'test set' ground truth establishment for the 510(k) submission.

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

This information is not applicable as the document describes non-clinical testing of a dental coloring liquid and does not involve human adjudication of results in a clinical study context.

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

An MRMC comparative effectiveness study was not done. This device is a dental coloring liquid, not an AI-assisted diagnostic tool.

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

This concept is not applicable to a dental coloring liquid. There is no algorithm or AI component in "Perfit CL."

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

For the non-clinical tests, the "ground truth" is established by adherence to internationally recognized standards (e.g., ISO 10993 for biocompatibility, ISO 6872 for performance) and precise laboratory measurements of physical and chemical properties. It is based on standardized laboratory methods and physical/chemical criteria, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This information is not applicable as the document describes non-clinical testing of a dental coloring liquid, not a machine learning or AI-based device that requires a "training set."

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

This information is not applicable as the document describes non-clinical testing of a dental coloring liquid, not a machine learning or AI-based device.

Summary

{0}------------------------------------------------

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

June 20, 2023

Vatech mcis Co., Ltd. % Dave Kim MTech Group 7505 Fannin St. Ste 610 Houston, Texas 77054

Re: K223029

Trade/Device Name: Perfit CL Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 22, 2023 Received: May 22, 2023

Dear Dave Kim:

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

{1}------------------------------------------------

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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., CQIA 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) K223029

Device Name

Perfit CL

Indications for Use (Describe)

Perfit CL can be used as an accessory to zirconium dioxide dental to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

510(k) Summary

K223029

The following 510(k) summary is being submitted as required by 21 CFR 807.92;

5.1 Submitter:	Vatech mcis Co., Ltd.C-Dong, 2544, Nambuk-daero, Idong-eup, Cheoin-gu,Yongin-si, Gyeonggi-do, South Korea (17137)Phone No. +82-31-8005-1855Fax No. +82-31-8005-1888
Contact Person:	Kim, Gyeong RokPhone: +82-31-8005-1855E-mail: gyeongrok.kim@vatechmcis.com
Official Correspondent:	Dave Kim, MBAMtech Group7505 Fannin St. Suite 610, Houston, TXTel: 713-467-2607E mail: davekim@mtechgroupllc.com
Date Prepared:	June 18, 2023

5.2 Device Identification

Device Trade Name	Perfit CL
Common Name	Coloring liquid for dental zirconium oxide ceramic
Classification Name, Number	Porcelain Powder for Clinical Use (21 CFR872.6660)
Device Classification	II
Product Code	EIH

5.3 Predicated or legally marketed devices which are substantially equivalent

· Primary Predicate device: K173769, "DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid", manufactured by "DMAX Co, Ltd."

5.4 Device Description

This medical device is used to color the zirconia pre- sintered body, and it is a color solution that makes the color similar to natural teeth by using a brush and immersion.

ર્સ્ડ Statement of Indication for use

{4}------------------------------------------------

Non-clinical Test Conclusion 5.6

The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.

Shelf- Life Test
= ISO 10993-3- Genotocixity (Ames test) & Genotocixity (Micronucleus)
= ISO 10993-5- Cytotoxicity
ISO 10993-10 Sensitization & Irritation
= ISO 10993-11 Acute systemic toxicity (Oral)
= Other bench testing- Appearance, Volume, Packaging, Dissolution analysis, Color stability

Bench test results allowed to conclude that Perfit CL 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 Packaging Volume, Shade and Storage Conditions between our device and the predicate devices.

No.	Item	Subject Device	Predicate Device	Remark
1	Device Name	Perfit CL	DMAX coloring liquidChang's liquidConfident coloring liquidCAMeleon coloring liquid
2	Manufacturer	Vatech mcis Co., Ltd	DMAX Co., Ltd.
3	510(k) Number	K223029	K173769
4	Product Code	EIH	EIH
5	Class	II	II
6	Review Panel	Dental	Dental
7	Technology	Water-based withinorganicpigments	Water-based withinorganicpigments	Same as predicate
8	Indications forUse	Perfit CL can be used as anaccessory to zirconiumdioxide dental restorativematerial to provideindividual tooth (or teeth)shading. It is intended to beused solely by certifieddental technicians forfabrication of zirconiumdioxide restorations forindividual dental patients	DMAX coloring liquid,Chang's liquid, Confidentcoloring liquid, andCAMeleon coloring liquidcan be used as an accessoryto zirconium dioxide dentalrestorative material toprovide individual tooth(or teeth) shading. It isintended to be used solelyby certified dentaltechnicians for fabricationof zirconium dioxiderestorations for individualdental patients.	Same as predicate
9	Principles ofOperation	Brush or immerse zirconiaceramic with coloringliquid before sintering	Brush or immerse zirconiaceramic with coloringliquid before sintering	Same as predicate
10	Prescription Use	Prescription only	Prescription only	Same as predicate
11	Targetpopulation	General, mostly adults	General, mostly adults	Same as predicate
12	Type ofPackaging	Liquid container	Liquid container	Same as predicate
13	PackagingVolume(ml)	20 and 50mL	15,20,30,40 and 100mL	No significant difference.The dose is different but itcan be differentiateddepending on experts'determination. That is,dose is not relevant toclinical performance andsafety.
14	Shade	27 colors	45 colors	No significant difference.The shade is different butit can be differentiateddepending on experts'determination. That is,dose is not relevant toclinical performance andsafety.
15	StorageConditions	2 years at 0-25 °C	1 year at 2-28 °C	No significant difference.The storage temperatureis a little different but thestorage temperature doesnot cause any clinicalperformance and safetyissue will not be causedby the storagetemperature if stored atthe recommendedstorage temperature.
16	GeneralPhysicalForm	Liquid	Liquid	Same as predicate
17	Sterility	Non-Sterile	Non-Sterile	Same as predicate
18	pH	5.5~8.0	5.5~8.0	Same as predicate
19	Boiling Point	100°C	100°C	Same as predicate
20	Density	1.00~1.10 g/cm^3	1.00~1.10 g/cm^3	Same as predicate
21	Specific Gravity(Relative Density)	1.00~1.10	1.00~1.10	Same as predicate
22	Solubility inWater	100%	100%	Same as predicate
24	Biocompatibilityy Testing	Tested to ISO 10993-1	Tested to ISO 10993-1	Same as predicate
25	PerformanceTesting	Tested to ISO 6872	Tested to ISO 6872	Same as predicate

Table 1. General Device Characteristics Comparison Table

{5}------------------------------------------------

Submitter: Vatech mcis Co., Ltd

Perfit CL Premarket Notification: Traditional 510(k)

{6}------------------------------------------------

The subject device is substantially equivalent to the predicate device, DMAX coloring liquid, Chang's liquid, Confident coloring liquid, CAMeleon coloring liquid, (K173769) made by DMAX Co., Ltd. Both the device has the same indications for Use and technological characteristics. They even have the same pH, boiling point, density and specific gravity range. Both devices are soluble in water. The raw material composition rate might be different between the devices, however, the subject device meets the requirements ISO 10993, therefore, this difference would not raise a question in substantial equivalence.

5.9	Conclusion	Based on the testing results, Vatech mcis Co., Ltd concludes that thesubject device is substantially equivalent to the predicate device.
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.

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.